Medtronic Open Pivot™

Medtronic Open Pivot™Heart Valve500, 501, 505

Instructions for Use

Caution: Federal law (USA) restricts this device to sale by or on theorder of a physician.

Trademarks may be registered and are the property of their respective owners.

1

Explanation of symbols on package labelingRefer to the device labeling to see which symbols apply to this product

Nonpyrogenic

Sterilized Using Steam

Size

Do Not Reuse

Do Not Resterilize

Use-By Date

Quantity

Open Here

Consult Instructions for Use

For US Audiences Only

Keep Dry

Date of Manufacture

Serial Number

Catalog Number

Manufacturer

Authorized Representative in the European Community

MR Conditional

Do Not Use if Package is Damaged

Manufactured In

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3 4

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9

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57

8

96

Figure 1. Standard heart valve

1. Inside diameter2. Geometric orifice3. Mitral valve4. Aortic valve5. Profile height6. Inflow height7. Outflow height8. Tissue annulus9. Blood flow

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3 4

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5 7

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88

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Figure 2. AP™ heart valve


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1 2

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3 4

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96

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Figure 3. AP360™ heart valve


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Figure 4. Double barrier tray package

1. Outer lid2. Inner lid3. Retainer4. Leaflet actuator5. Heart valve6. Valve holder7. Handle rotator8. Inner tray9. Outer tray

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Figure 5. Aortic valve holder and handle rotator assembly (leaflets inside holder)

1. Radial ridge

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Figure 6. Mitral valve holder and handle rotator assembly

1. Radial ridge

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Figure 7. Standard heart valve sizer

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Figure 8. AP™ heart valve sizer

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Figure 9. Bendable handle

1. Flexible support

10 Instructions for Use English

Heart Valve1. Device DescriptionThe Medtronic Open Pivot™ heart valve (Models 500, 501, and 505) is a low profile bileaflet valveprosthesis consisting of pyrolytic carbon orifice ring and leaflets (Figure 1, Figure 2, and Figure 3).The prosthesis consists of an orifice housing 2 mirror image leaflets. The low profile of the prosthesisresults from the bileaflet design where the pivot areas are located entirely within the orifice ring, whichminimizes the overall height of the valve. Pivot guides located on the inner circumference of the orifice ringcontrol the range of leaflet motion. The pivot geometry consists of arc-shaped notches at either end ofeach leaflet and spherical protrusions at 4 places on the orifice. Each leaflet rotates around 2 opposingspheres. There are inflow and outflow stops adjacent to each sphere on the orifice. The inflow and outflowstops limit the rotation of the leaflets. There are no recesses or cavities in the pivot area. The leaflets opento an approximate angle of 85 degrees and close to a maximum angle of approximately 25 degrees.The leaflets consist of pyrolytic carbon coated over a graphite substrate. The graphite substrate isimpregnated with 20% tungsten for radiopacity. The orifice consists entirely of pyrolytic carbon.The valve sewing cuff is constructed of double velour polyester fabric mounted on the orifice using atitanium or MP35N, a cobalt-chromium alloy, stiffening ring and secured with two titanium lock rings and alock wire. This method of sewing cuff attachment to the orifice allows for rotation of the sewing cuff in situduring surgical placement. The sewing cuff of mitral sizes 25 mm through 33 mm contains apolytetrafluoroethylene (PTFE) liner inside the double velour polyester fabric.The Medtronic Open Pivot heart valve is available in the aortic and mitral configurations in several sewingcuff styles: the standard, AP™, and AP360™. The AP™ series valves are supra-annular configurations ofthe standard heart valve. Three cuff markers are located in the aortic cuff and 4 cuff markers are located inthe mitral cuff to assist in the uniform placement of sutures around the valve annulus.The valves are available in the dimensions and sizes shown in Table 1 through Table 6.

Table 1. Medtronic Open Pivot Standard Heart Valve Specifications (Aortic)

Valve Size(mm)

Model Number Overall ProfileHeight (mm)

Inside Diame-ter (mm)

Tissue AnnulusDiameter (mm)

Orifice Area(cm2)

19 500FA19 9.3 14.8 19.2 1.5521 500FA21 10.3 16.8 21.2 2.0223 500FA23 11.3 18.8 23.2 2.5625 500FA25 12.3 20.8 25.2 3.1727 500FA27 13.3 22.8 27.2 3.8429 500FA29 14.3 24.8 29.2 4.59

Table 2. Medtronic Open Pivot Standard Heart Valve Specifications (Mitral)

Valve Size(mm)




Orifice Area(cm2)

25 500DM25 12.3 20.8 25.2 3.1727 500DM27 13.3 22.8 27.2 3.8429 500DM29 14.3 24.8 29.2 4.5931 500DM31 15.4 26.8 31.2 5.3533 500DM33 15.4 26.8 33.2 5.3535 500DM35 15.4 26.8 35.2 5.35

Table 3. Medtronic Open Pivot AP Heart Valve Specifications (Aortic)

Valve Size(mm)




Orifice Area(cm2)

16 501DA16 9.3 14.8 16.2 1.5518 501DA18 10.3 16.8 18.2 2.0220 501DA20 11.3 18.8 20.2 2.5622 501DA22 12.3 20.8 22.2 3.1724 501DA24 13.3 22.8 24.2 3.8426 501DA26 14.3 24.8 26.2 4.59

Table 4. Medtronic Open Pivot AP Heart Valve Specifications (Mitral)

Valve Size(mm)




Orifice Area(cm2)

22 501DM22 12.3 20.8 22.2 3.1724 501DM24 13.3 22.8 24.2 3.8426 501DM26 14.3 24.8 26.2 4.5928 501DM28 15.4 26.8 28.2 5.35

Instructions for Use English 11

Table 5. Medtronic Open Pivot AP360 Heart Valve Specifications (Aortic)

Valve Size(mm)



Tissue Annu-lus Diameter(mm)

Orifice Area(cm2)

16 505DA16 9.3 14.8 16.2 1.5518 505DA18 10.3 16.8 18.2 2.0220 505DA20 11.3 18.8 20.2 2.5622 505DA22 12.3 20.8 22.2 3.1724 505DA24 13.3 22.8 24.2 3.8426 505DA26 14.3 24.8 26.2 4.59

Table 6. Medtronic Open Pivot AP360 Heart Valve Specifications (Mitral)

Valve Size(mm)



Tissue Annu-lus Diameter(mm)

Orifice Area(cm2)

22 505DM22 12.3 20.8 22.2 3.1724 505DM24 13.3 22.8 24.2 3.8426 505DM26 14.3 24.8 26.2 4.5928 505DM28 15.4 26.8 28.2 5.35

2. Indications for UseThe Medtronic Open Pivot heart valve is indicated for the replacement of diseased, damaged, ormalfunctioning native or prosthetic aortic or mitral valves.

3. ContraindicationsThe Medtronic Open Pivot heart valve is contraindicated in patients unable to tolerate anticoagulationtherapy.

4. Warnings and Precautions4.1. Warnings■ This device was designed for single patient use only. Do not reuse, reprocess, or resterilize this

product. Reuse, reprocessing, or resterilization may compromise the structural integrity of the deviceand/or create a risk of contamination of the device, which could result in patient injury, illness, or death.

■ Avoid damaging the prosthesis. Only handle the prosthesis with the accessories provided byMedtronic. Touching the valve with gloved fingers or any surgical instrument may cause damage to thevalve surface that cannot be seen with the unaided eye. Such damage may serve as a nidus forthrombus formation. The damage may also lead to leaflet escape or accelerated structuraldeterioration of the valve.

■ Do not pass a catheter through the prosthesis as this may cause valvular insufficiency, leafletdislodgment, or catheter entrapment.

■ Do not apply force to the leaflets, attempt to change the position of the leaflets, or remove a leaflet.■ Patients allergic to cobalt-chromium or nickel may suffer an allergic reaction, specifically to the AP360

device.

4.2. Precautions Prior to Use■ Do not use the Medtronic Open Pivot heart valve if the prosthesis has been dropped, damaged, or

mishandled in any way. Should the valve be damaged during implantation or removal from thepackage, do not use for implantation.

■ Do not use the Medtronic Open Pivot heart valve if the tamper evident seal is broken or the Use-ByDate has elapsed.

4.3. Precautions During Use■ Use only the Medtronic Open Pivot heart valve sizer to select the proper valve size as other sizers

may result in improper valve selection.■ When a valve is released from a holder and implanted without using the holder, implant it with

attention to the valve orientation.■ When seating the valve, ensure that no suture material or anatomic structures interfere with leaflet

motion. Rotate the valve to avoid abnormal residual pathology that could interfere with leaflet motion.■ Use only taper point needles for suturing the cuff as taper cut or other cutting needles may cut the cuff

fibers.

5. Adverse EventsA total of 965 Medtronic Open Pivot heart valves were implanted in 965 patients at 20 centers. The meanfollow-up was 1.4 years (range 0 to 5 years) with a total of 1323 patient-years. A total of 56 deathsoccurred during the study and 20 of these were characterized as valve related. The causes of valve-related deaths were endocarditis (2 patients), paravalvular leak (1 patient), thromboembolism (3 patients),anticoagulant-related hemorrhage (10 patients), and unknown (4 patients).

5.1. Observed Adverse EventsTable 7 shows the observed adverse events for early events (occurring ≤30 days postimplant), thelinearized rates for late events (occurring >30 days postoperatively), and the actuarial adverse event ratesat 1 and 5 years postoperatively.


Table 7. Observed Adverse Events (Aortic Valve Replacement)

Early Events Late Events Actuarial Freedom by Kaplan-Meier

% of pts (N) %/pt-yr (N) 1 Year [95% CI] 5 Years [95% CI]All patients implanted: N=685, Cumulative Follow-up=866.4 patient yearsDeaths (all causes) 2.04% (14) 2.77% ± 1.06% (24) .9735 [± .01] .9031 [± .05]

Death (valve-rela-ted/unexplained)

0.58% (4) 1.15% ± 0.74% (10) .9817 [± .01] .9539 [± .03]

Anticoagulant-RelatedHemorrhage (All)

4.67% (32) 1.96% ± 0.91% (17) .9781 [± .01] .9340 [± .04]

Anticoagulant-RelatedHemorrhage (Major)

3.21% (22) 1.27% ± 0.76% (11) .9878 [± .01] .9473 [± .04]

Thromboembolism (All) 1.75% (12) 2.08% ± 0.93% (18) .9733 [± .01] .9283 [± .05]Permanent Neurologi-cal Events

0.88% (6) 0.69% ± 0.60% (6) .9920 [± .01] .9706 [± .04]

Transient NeurologicalEvents

0.88% (6) 1.39% ± 0.78% (12) .9812 [± .01] .9564 [± .03]

Valve Thrombosis 0.00% (0) 0.00% ± 0.00% (0) 1.000 [± .00] 1.000 [± .00]Perivalvular Leak (All) 0.15% (1) 0.46% ± 0.52% (4) .9966 [± .00] .9898 [± .01]

Perivalvular Leak(Major)

0.15% (1) 0.12% ± 0.33% (1) .9983 [± .00] .9983 [± .00]

Endocarditis 0.00% (0) 0.35% ± 0.46% (3) .9960 [± .01] .9908 [± .01]Hemolysis 0.00% (0) 0.00% ± 0.00% (0) 1.000 [± .00] 1.000 [± .00]Structural Dysfunction 0.00% (0) 0.00% ± 0.00% (0) 1.000 [± .00] 1.000 [± .00]Nonstructural Dysfunction 0.00% (0) 0.00% ± 0.00% (0) 1.000 [± .00] 1.000 [± .00]Reoperation 0.15% (1) 0.35% ± 0.46% (3) .9961 [± .01] .9914 [± .01]Explant 0.00% (0) 0.23% ± 0.41% (2) .9978 [± .00] .9931 [± .01]

Notes:1. Cumulative probability of freedom from event estimate at the end of the interval (Pc) is based on the

Kaplan-Meier method.2. The 95% confidence interval bound for the cumulative freedom rate at the end of the

interval = 1.96 X SE, where SE is the standard error estimate of the cumulative probability freedomfrom a heart valve related or an unexplained event estimate calculated using Greenwood’s formula.

3. The actuarial hazard rate estimates are calculated at the midpoint of each interval.4. The 95% confidence interval bound for the hazard rate at the midpoint of each interval = 1.96 X SE,

where SE is the standard error estimate of the hazard rate estimate at the midpoint of the interval.

Table 8. Observed Adverse Events (Mitral Valve Replacement)

Early Events Late Events Actuarial Freedom by Kaplan-Meier

% of pts (N) %/pt-yr (N) 1 Year [95% CI] 5 Years [95% CI]All patients implanted: N=280, Cumulative Follow-up=374.7 patient yearsDeaths (all causes) 1.79% (5) 3.47% ± 1.88% (13) .9814 [± .02] .8099 [± .11]

Death (valve-rela-ted/unexplained)

0.71% (2) 1.07% ± 1.19% (4) .9831 [± .02] .9342 [± .07]

Anticoagulant-RelatedHemorrhage (All)

3.21% (9) 0.53% ± 0.95% (2) .9958 [± .01] .9673 [± .06]

Anticoagulant-RelatedHemorrhage (Major)

3.21% (9) 0.53% ± 0.95% (2) .9958 [± .01] .9673 [± .06]

Thromboembolism (All) 3.21% (9) 4.00% ± 2.00% (15) .9534 [± .03] .8589 [± .09]Permanent Neurologi-cal Events

1.79% (5) 0.80% ± 1.08% (3) .9910 [± .01] .9807 [± .02]

Transient NeurologicalEvents

1.43% (4) 3.20% ± 1.82% (12) .9621 [± .03] .8758 [± .09]

Valve Thrombosis 0.00% (0) 0.53% ± 0.95% (2) .9947 [± .01] .9866 [± .02]Perivalvular Leak (All) 0.71% (2) 1.07% ± 1.19% (4) .9819 [± .02] .9819 [± .02]


0.36% (1) 0.53% ± 0.95% (2) .9915 [± .01] .9915 [± .01]

Endocarditis 0.36% (1) 0.53% ± 0.95% (2) .9957 [± .01] .9861 [± .02]Hemolysis 0.00% (0) 0.53% ± 0.95% (2) .9952 [± .01] .9814 [± .03]Structural Dysfunction 0.00% (0) 0.00% ± 0.00% (0) 1.000 [± .00] 1.000 [± .00]Nonstructural Dysfunction 0.00% (0) 0.00% ± 0.00% (0) 1.000 [± .00] 1.000 [± .00]Reoperation 0.71% (2) 1.07% ± 1.19% (4) .9874 [± .01] .9697 [± .03]Explant 0.36% (1) 0.53% ± 0.95% (2) .9959 [± .01] .9783 [± .03]


Notes:1. Cumulative probability of freedom from event estimate at the end of the interval (Pc) is based on the

Kaplan-Meier method.2. The 95% confidence interval bound for the cumulative freedom rate at the end of the

interval = 1.96 X SE, where SE is the standard error estimate of the cumulative probability freedomfrom a heart valve related or an unexplained event estimate calculated using Greenwood’s formula.

3. The actuarial hazard rate estimates are calculated at the midpoint of each interval.4. The 95% confidence interval bound for the hazard rate at the midpoint of each interval = 1.96 X SE,

where SE is the standard error estimate of the hazard rate estimate at the midpoint of the interval.

5.2. Potential Adverse EventsAdverse events potentially associated with the use of prosthetic aortic heart valves include, but are notlimited to:■ angina■ cardiac arrhythmia■ endocarditis■ hemolysis■ hemolytic anemia■ hemorrhage, anticoagulation-related■ myocardial infarction■ leaflet entrapment (impingement)■ nonstructural dysfunction■ pannus■ perivalvular leak■ transvalvular regurgitation■ structural dysfunction■ thrombosis■ stroke■ thromboembolismIt is possible that these complications could lead to:■ reoperation■ explantation■ permanent disability■ heart failure■ death

6. Instructions for Use6.1. Physician TrainingNo special training is required to implant the Medtronic Open Pivot heart valve. The techniques forimplanting this valve are similar to those used for any bileaflet mechanical valve.

6.2. Handling and Preparation InstructionsProper prosthesis size selection is an important part of the heart valve replacement. The size of theMedtronic Open Pivot heart valve is determined using the Medtronic Open Pivot™ heart valve sizers.Caution: The valve accessories (sizer and handle) should not be used unless cleaned and sterilized asper the recommended instructions in the Medtronic Open Pivot™ heart valve accessories Instructions forUse.The valve, valve holder, handle rotator, and leaflet actuator are supplied sterile in the same package. Thecontents of the package should be handled in an aseptic manner to prevent contamination.1. Remove the package from the white shipping box along with the Patient Registration Form. Verify that

the valve size, type, and serial number as marked on the tray label, match the information on the whiteshipping box label. If any differences are noted, do not use the valve for implantation.

2. Examine the lid to verify that the prosthesis container has not been damaged or previously opened. Ifresterilization of accessories is necessary prior to implantation, follow the recommended cleaning andsterilization guidelines.

3. Hold the outer tray and gently peel the lid back using sterile techniques until the lid has beencompletely removed from the tray.

4. Record the serial number of the valve in the patient’s record using the stickers provided on the PatientRegistration Form.

5. Remove the inner tray from the outer tray by grasping the inner tray by its lip.6. Holding the bottom of the inner tray, grasp the inner tray lid tab and peel back until the lid has been

completely removed.7. Using sterile technique, carefully remove the retainer insert and discard.8. Verify that the valve holder is secured to the handle rotator before removing the valve holder and

handle rotator assembly from the inner tray. There should be no visible screw threads at theconnection between the colored handle rotator and the valve holder when secured properly.

9. Remove the blue leaflet actuator from the tray and set aside for later use.


10. Grasp the handle rotator in the center and gently lift the valve, valve holder, and handle rotator out ofthe inner tray. Do not remove the valve from the valve holder unless instructed by the implantingsurgeon.

6.3. Device ImplantationProper prosthesis size selection is an important part of heart valve replacement. Care must be exercisedto avoid using too large or too small of a prosthesis. Size of the prosthesis is determined using theMedtronic Open Pivot heart valve sizers (Figure 7 and Figure 8).Inspection of the valve should be performed immediately before implantation.Warning: Do not touch the valve (leaflets/orifice) except with the leaflet actuator supplied with the valve.Touching the valve with gloved fingers or any surgical instrument may cause damage to the valve surfacethat cannot be seen with the unaided eye. Such damage may serve as a nidus for thrombus formation.The damage may also lead to leaflet escape or accelerated structural deterioration of the valve.Caution: Do not use the valve if it has been dropped, damaged, or mishandled in any way. Should thevalve be damaged during implantation or removal from the package, do not use it for implantation.Use only accessories provided by Medtronic to handle the valve. All accessories should be inspected priorto use. Do not use any accessory if the surface appears damaged or cracked.

6.4. Suturing TechniquesEnsure proper orientation of the valve. The blood flow in either the aortic or mitral position is always intothe straight edge of the leaflets. The markers on the sewing cuff (3 on the aortic cuff and 4 on the mitralcuff) are useful in proper placement of the sutures and orientation of the valve. The aortic markers are120° apart and may be placed at the approximate location of the commissures of the excised valve. Themitral cuff has 4 markers 90° apart, that can be placed at each commissure, in the center of the anteriorleaflet, and in the center of the posterior leaflet. If necessary, further orientation of the valve can be donewith the handle rotator once the valve is seated in the annulus.Medical practice has evolved numerous acceptable suture methods. The technique used should be basedon the patient’s anatomy, procedure requirements, and surgeon preference. Pledgets may be used at thediscretion of the surgeon for support of the annulus if necessary. Care should be taken to assure thatpledgets or tissue do not interfere with leaflet motion. Everting stitches with pledgets may be useful inavoiding situations where tissue might impede leaflet motion.After sutures are placed in the valve cuff and the valve is seated in the tissue annulus, the valve isreleased from the valve holder by sliding a scalpel down the holder slot to cut the green suture andrelease the valve holder. The green suture and valve holder remain attached as the holder and handlerotator are carefully withdrawn. The suture knots can be tied at this point.Caution: Long suture ends must be avoided since these can interfere with leaflet motion.

6.4.1. Suturing Technique for Standard CuffsSurgeons performing mitral and aortic valve replacements frequently use interrupted everting mattresssutures. Alternatives include interrupted figure of 8 sutures or interrupted simple mattress sutures.

6.4.2. Suturing Technique for AP Series Heart ValvesThe Medtronic Open Pivot AP series heart valves have a supra-annular configuration. Different suturetechniques, such as horizontal mattress or simple stitch, may be necessary. Deep needle placement willcontact the strengthening band inside the sewing cuff, impeding the smooth placement of sutures. Suturesshould be placed in the outer 1/3 of the cuff.

6.5. Leaflet Motion Assessment and Valve RotationLeaflet motion is assessed using the blue leaflet actuator.To test leaflet motion, use the blue leaflet actuator. If the leaflets do not move freely, the valve orifice maybe rotated either clockwise or counterclockwise to a more optimal position. Before implanting the device,check freedom of rotation by holding the valve cuff and gently turning the valve holder and handle rotator.Rotate the orifice only after the suture knots have been tied to secure the cuff to the tissue annulus. Useonly the appropriate rotators provided to rotate the valve. The handle rotator seats properly into the valveorifice when the radial ridge on the handle side of the rotator head (Figure 5 and Figure 6) is aligned withthe straight edge of the leaflets. The rotator head is designed to contact the flat surfaces of the orifice nearthe pivot areas. After rotation of the valve orifice, verify leaflet motion with the blue actuator.Caution: The valve orifice and leaflets may be rotated in situ using only the appropriate handle rotatorprovided. Do not use any other instruments for valve rotation.Caution: If mitral valve apparatus preservation techniques are used, it is important to check leaflet motionfollowing valve implantation.

6.6. Sterilization InformationThe Medtronic Open Pivot heart valve and package contents have been steam sterilized within the trays.The valve is ready for use when received. Do not use the valve if the Use-By Date has passed or if, uponremoval from the outer box, the valve container is damaged or the sterility barrier is broken. Call aMedtronic local representative and arrange to return the valve and receive a replacement.The sizers and bendable handles are supplied nonsterile and must be cleaned and sterilized prior to use.Refer to the accessories Instructions for Use for cleaning and sterilization instructions.Warning: If, during surgery, the valve is removed from its container but not used, it must not berepackaged or resterilized.Caution: Extreme care must be exercised when handling the valve holder assembly to avoid structuraldamage to the valve. Inspect each accessory before each use. Cracked or damaged accessories must notbe used.


7. Clinical StudiesThis section contains the results of 3 separate sets of clinical data.1. Prospective investigational studies, 1994 to 1999.2. Additional clinical data on sizes 16/19 mm aortic valves and 24/27 mm mitral valves.3. Additional clinical data on size 22/25 mm mitral valves.

7.1. Prospective Investigational Studies, 1994 to 1999Patients requiring isolated aortic or mitral heart valve replacement were enrolled from 1994 to 1999 at20 centers (17 domestic and 3 international) in a multicenter, international, prospective, nonrandomizedstudy. NYHA classification and blood data were obtained preoperatively, intraoperatively, andpostoperatively at 3 to 6 months, at 1 year, and annually thereafter. Hemodynamic data was obtained atdischarge and at 1 year. Patients were monitored throughout the postoperative period for possible adverseevents. The antiplatelet and anticoagulant agents used were reported. Target INRs were as follows: mitralposition, 2.5 to 3.5, and aortic position, 2.0 to 3.0 (when in normal sinus rhythm).The cohort included 965 patients (580 men, 385 women), ages from 2 to 88 years (mean of 60.7). Thecumulative follow-up was 1323 patient-years with a mean follow-up of 1.4 years (SD = 1.2 years,range = 0 to 5.0 years). Table 9 shows patient characteristics by age, gender, and etiology of valvedisease.

Table 9. Patient Characteristics

All patients implanted, N=965, 1323 patient-yearsDescription of Patients Aortic Valve n=685 (70.98%) Mitral Valve n=280 (29.02%)Age at implant in years0–9 5 (0.7%) 6 (2.1%)10–19 4 (0.6%) 0 (0.0%)20–29 11 (1.6%) 2 (0.7%)30–39 33 (4.8%) 14 (5.0%)40–49 72 (10.5%) 31 (11.1%)50–59 142 (20.7%) 52 (18.6%)60–69 238 (34.7%) 107 (38.2%)70–79 155 (22.6%) 62 (22.1%)80 & over 25 (3.6%) 6 (2.1%)Gender

Male 460 (67.2%) 120 (42.9%)Female 225 (32.8%) 160 (57.1%)

Etiology of valve diseaseStenosis 541 (79.0%) 118 (42.1%)Insufficiency 330 (48.2%) 210 (75.0%)Mixed 205 (29.9%) 63 (22.5%)Other 12 (1.8%) 12 (4.3%)

Figure 10 shows the number of patients implanted versus duration of follow-up with a breakdown by valvelocation (aortic and mitral). Table 10 shows the number of patients implanted for whom hemodynamic datawas collected. Table 11 shows the number of patient-years by implant size andlocation. Table 12, Table 13, Table 14,Table 15, and Table 16 show effectiveness outcomes.

Duration of Follow-up (Years)

Nu

mb

er

of P

atie

nts

Total Patients Aortic Patients Mitral Patients

1000

800

600

400

200

0

0 1 2 3 4 5

Figure 10. Number of patients by implant location over time


All patients implanted, N=965Year 0 1 2 3 4 5Total Patients 965 624 331 135 92 2AorticPatients

685 436 231 93 58 2

MitralPatients

280 188 100 42 34 0

Table 10. Number of Patients Implanted and Maximum Number of Patients with Hemodynamic Data at>6 Months Follow-up

By implant location and valve size, N/n, n=575, N=965Implant Location Valve size (mm)

16/19 18/21 20/23 22/25 24/27 26/29 28/31/33 TotalAortic 23/172 100/61 202/108 206/113 111/70 39/32 4/4 685/405Mitral 0/0 3/1 5/4 3/2 23/182 71/39 175/106 280/170Total 23/17 103/62 207/112 209/115 134/88 110/71 179/110 965/575

Notes:1. n = number of patients with hemodynamic data; N = number of patients implanted2. Includes data from 8 patients for the 16/19 mm aortic valve and 10 patients for the 24/27 mm mitral

valve not included in the analysis of the original patient cohort.

Table 11. Number of Patient-Years by Implant Location and Valve Size

By implant location and valve size, all patients implanted, N=965ImplantLoca-tion

Valve size (mm)16/19 18/21 20/23 22/25 24/27 26/29 28/31 33 Total

Aortic 15.7 159.3 275.0 255.6 150.1 61.1 7.4 0.0 924.2Mitral 0.0 2.2 4.8 2.4 17.6 99.8 97.7 174.0 398.5Total 15.7 161.5 279.8 258.0 167.7 160.9 105.1 174.0 1322.7

Table 12. Effectiveness Outcomes, Functional New York Heart (NYHA) Classification

NYHAClass

Pre-op 1 Year(11–14 Months)

2 Year(23–26 Months)



n/N % n/N % n/N % n/N % n/N %Aortic Valve Replacement, N=685

I 4/685 0.6% 399/431 92.5% 205/231 88.7% 85/94 90.4% 53/58 91.4%II 267/685 38.9% 25/431 5.8% 20/231 8.7% 7/94 7.4% 5/58 8.6%III 340/685 49.6% 1/431 0.2% 1/231 0.4% 0/94 0% 0/58 0%IV 68/685 9.9% 1/431 0.2% 1/231 0.4% 0/94 0% 0/58 0%

MISSING 6/685 0.9% 5/431 1.2% 4/231 1.7% 2/94 2.1% 0/58 0%Mitral Valve Replacement, N=280

I 0/280 0% 158/182 86.8% 78/100 78.0% 33/42 78.5% 28/34 82.4%II 74/280 26.4% 19/182 10.4% 19/100 19.0% 8/42 19.0% 5/34 14.7%III 155/280 55.4% 3/182 1.6% 2/100 2.0% 1/42 2.4% 1/34 2.9%IV 45/280 16.1% 0/182 0% 0/100 0% 0/42 0% 0/34 0%

MISSING 6/280 2.1% 2/182 1.1% 1/100 1.0% 0/42 0% 0/34 0%Note: N = all values reported; n = number in subgroup

Table 13. Late Effectiveness Outcomes — Hemodynamics, Valvular Regurgitation (Aortic Valves)

Valve Size(mm)

No Regurgita-tion

% patients, n/N

Trivial Regurgi-tation

% patients, n/N

Mild Regurgi-tation

% patients, n/N

ModerateRegurgitation

% patients, n/N

Severe Regur-gitation

% patients, n/NAortic Valves, N=685

16/19 mm 33.3%, 3/9 66.7%, 6/9 0%, 0/9 0%, 0/9 0%, 0/918/21 mm 39.6%, 21/53 58.5%, 31/53 1.9%, 1/53 0%, 0/53 0%, 0/5320/23 mm 33.0%, 31/94 67.0%, 63/94 0%, 0/94 0%, 0/94 0%, 0/9422/25 mm 28.3%, 28/99 71.7%, 71/99 0%, 0/99 0%, 0/99 0%, 0/9924/27 mm 42.6%, 26/61 55.7%, 34/61 1.6%, 1/61 0%, 0/61 0%, 0/6126/29 mm 27.3%, 6/22 72.7%, 16/22 0%, 0/22 0%, 0/22 0%, 0/2228/31 mm 100%, 4/4 0%, 0/4 0%, 0/4 0%, 0/4 0%, 0/4

Aortic Totals 34.8%, 119/342 64.6%, 221/342 0.6%, 2/342 0%, 0/342 0%, 0/342

Notes:1. Late is defined as 11–14 months postimplantation2. N = all values reported; n = number in subgroup


Table 14. Late Effectiveness Outcomes — Hemodynamics, Valvular Regurgitation (Mitral Valves)

Valve Size(mm)

No Regurgita-tion

% patients, n/N


% patients, n/N

Mild Regurgi-tation

% patients, n/N


% patients, n/N


% patients, n/NMitral Valves, N=280

16/19 mm 0%, 0/0 0%, 0/0 0%, 0/0 0%, 0/0 0%, 0/018/21 mm 0%, 0/0 0%, 0/0 0%, 0/0 0%, 0/0 0%, 0/020/23 mm 66.7%, 2/3 33.3%, 1/3 0%, 0/3 0%, 0/3 0%, 0/322/25 mm 50.0%, 1/2 50.0%, 1/2 0%, 0/2 0%, 0/2 0%, 0/224/27 mm 83.3%, 5/6 16.7%, 1/6 0%, 0/6 0%, 0/6 0%, 0/626/29 mm 54.5%, 18/33 42.4%, 14/33 3.0%, 1/33 0%, 0/33 0%, 0/33

28/31/33 mm 61.2%, 52/85 37.6%, 32/85 1.2%, 1/85 0%, 0/85 0%, 0/85Mitral Totals 60.5%, 78/129 38.0%, 49/129 1.6%, 2/129 0%, 0/129 0%, 0/129


Table 15. Effectiveness Outcomes — Hemodynamics, Mean Pressure Gradient and Effective Orifice Area(Aortic Valve Replacement)

Endpoint Earlyn/N, mean ± SD (min, max)

Laten/N, mean ± SD (min, max)

Aortic Valve Replacement, N=685Mean Gradient (mm Hg)

16/19 mm 15/23, 25.8 ± 5.1 (10.5, 49.0) 9/23, 20.2 ± 2.8 (15.0, 26.6)18/21 mm 87/100, 18.7 ± 1.7 (2.4, 42.0) 61/100, 18.0 ± 1.6 (7.0, 36.0)20/23 mm 181/202, 14.3 ± 0.8 (2.6, 37.0) 107/202, 13.1 ± 0.8 (5.1, 30.1)22/25 mm 187/206, 12.8 ± 0.8 (2.6, 29.5) 112/206, 11.1 ± 0.8 (3.2, 26.0)24/27 mm 102/111, 10.0 ± 0.7 (1.8, 22.0) 70/111, 8.0 ± 0.8 (1.3, 16.7)26/29 mm 38/39, 9.2 ± 1.1 (3.5, 18.0) 32/39, 7.8 ± 1.1 (2.0, 13.0)28/31 mm 3/4, 3.0 ± 0.7 (2.6, 3.8) 4/4, 5.1 ± 3.3 (1.4, 9.3)

Effective Orifice Area (cm2)16/19 mm 11/23, 1.1 ± 0.2 (0.7, 1.8) 8/23, 1.2 ± 0.3 (0.8, 1.9)18/21 mm 81/100, 1.5 ± 0.1 (0.8, 3.7) 60/100, 1.5 ± 0.1 (0.7, 3.4)20/23 mm 165/202, 1.7 ± 0.1 (0.8, 6.6) 102/202, 1.7 ± 0.1 (0.9, 3.7)22/25 mm 173/206, 2.0 ± 0.1 (1.1, 4.0) 103/206, 2.1 ± 0.1 (1.0, 4.9)24/27 mm 97/111, 2.4 ± 0.2 (1.1, 4.8) 65/111, 2.5 ± 0.2 (1.5, 4.9)26/29 mm 34/39, 3.0 ± 0.3 (1.4, 4.7) 28/39, 3.1 ± 0.4 (1.4, 5.4)28/31 mm 3/4, 2.8 ± 0.8 (2.0, 3.4) 3/4, 3.1 ± 1.6 (1.6, 4.5)

Notes:1. Early postoperative evaluation conducted at 30 days postimplantation or hospital discharge.2. Late postoperative evaluation = 11–14 months postimplantation3. N = all values reported; n = number in subgroup4. Echo confirmed valve function.

Table 16. Effectiveness Outcomes — Hemodynamics, Mean Pressure Gradient and Effective Orifice Area(Mitral Valve Replacement)



Mitral Valve Replacement, N=280Mean Gradient (mm Hg)

16/19 mm 0 018/21 mm 0/3 1/3,6.0 (6.0, 6.0)20/23 mm 3/5, 5.3 ± 3.6 (3, 9) 4/5, 4.6 ± 0.9 (4.0, 6.0)22/25 mm 1/3, 10.0 (10, 10) 2/3, 5.4 ± 4.7 (3.0, 7.8)24/27 mm 15/23, 4.4 ± 0.9 (2.3, 7.9) 8/23, 4.5 ± 0.9 (2.4, 6.2)26/29 mm 66/71, 3.7 ± 0.4 (1.5, 10.0) 39/71, 3.7 ± 0.7 (1.3, 9.9)

28/31/33 mm 154/175, 3.5 ± 0.3 (0.7, 9.0) 106/175, 3.1 ± 0.2 (0.3, 7.3)Effective Orifice Area (cm2)

16/19 mm 0 018/21 mm 0/3 1/34

20/23 mm 3/5, 2.9 ± 0.6 (2.3, 3.3) 3/5, 1.6 ± 0.3 (1.3, 1.8)22/25 mm 1/3, 1.6 (1.6, 1.6) 2/3, 1.8 ± 0.5 (1.5, 2.0)24/27 mm 15/23, 3.3 ± 0.5 (1.8, 5.2) 8/23, 2.9 ± 0.9 (1.6, 5.7)




Mitral Valve Replacement, N=280Mean Gradient (mm Hg)

26/29 mm 63/71, 3.3 ± 0.2 (1.6, 5.0) 38/71, 2.8 ± 0.3 (1.0, 4.6)28/31/33 mm 140/175, 3.0 ± 0.2 (1.3, 7.6) 95/175, 2.9 ± 0.2 (1.5, 7.4)

Notes:1. Early postoperative evaluation conducted at 30 days postimplantation or hospital discharge.2. Late postoperative evaluation = 11–14 months postimplantation3. N = all values reported; n = number in subgroup4. Echo confirmed valve function.

7.2. Additional Clinical Data on Sizes 16/19 mm Aortic Valve and 24/27 mm Mitral ValveMedtronic obtained additional follow-up clinical data for patients receiving the 16/19 mm aortic and the24/27 mm mitral valves. The following are the clinical results of the additional patient data. Thisinformation is presented both independently and in combination with the clinical data obtained in theoriginal patient cohort.The only adverse events reported are 1 minor and 1 major late anticoagulant-related bleeding events forthe 16/19 mm aortic valve. No adverse events or deaths were reported for the 24/27 mm mitral valve. Nodeaths were reported for the 16/19 mm aortic valve.

Table 17. Observed Adverse Events — Original Patient Cohort and Additional Data on 16/19 mm Aorticand 24/27 Mitral Valves

Early Events Late Events Actuarial Freedom by Kaplan-Meier% of pts (N) %/pt-yrs (N) 1 Year [95% CI] 5 Years [95% CI]

Aortic Valve Replacement, All patients implanted: N=685, Cumulative Follow-up=887.0 patient yearsAnticoagulant-Related Hem-orrhage (All)

4.60% (32) 2.01% ± 0.88% (19) .9785 [± .01] .9320 [± .02]

Anticoagulant-Related Hem-orrhage (Major)

3.16% (22) 1.27% ± 0.72% (12) .9881 [± .01] .9450 [± .02]

Table 18. Effectiveness Outcomes — Functional New York Heart (NYHA) Classification Additional Dataon 16/19 mm and 24/27 mm Mitral Valves

NYHAClass





n/N % n/N % n/N % n/N % n/N %16/19 mm Aortic Valve Replacement, N=10

I 0/10 0% 9/10 90% 2/3 66.7% 0/0 0% 0/0 0%II 3/10 30% 1/10 10% 0/3 0% 0/0 0% 0/0 0%III 6/10 60% 0/10 0% 1/3 33.3% 0/0 0% 0/0 0%IV 1/10 10% 0/10 0% 0/3 0% 0/0 0% 0/0 0%

MISSING 0/10 0% 0/10 0% 0/3 0% 0/0 0% 0/0 0%24/27 mm Mitral Valve Replacement, N=10

I 0/10 0% 7/10 70% 2/3 66.7% 0/0 0% 0/0 0%II 2/10 20% 2/10 20% 0/3 0% 0/0 0% 0/0 0%III 5/10 50% 0/10 0% 1/3 33.3% 0/0 0% 0/0 0%IV 3/10 30% 0/10 0% 0/3 0% 0/0 0% 0/0 0%

MISSING 0/10 0% 1/10 10% 0/3 0% 0/0 0% 0/0 0%Note: N = all values reported; n = number in subgroup

Table 19. Effectiveness Outcomes — Functional New York Heart (NYHA) Classification Original PatientCohort and Additional Data on 16/19 mm and 24/27 mm Mitral Valves

NYHAClass





n/N % n/N % n/N % n/N % n/N %Aortic Valve Replacement, N=685

I 4/685 0.6% 408/441 92.5% 207/234 88.5% 85/94 90.4% 53/58 91.4%II 267/685 38.9% 26/441 5.9% 20/234 8.5% 7/94 7.4% 5/58 8.6%III 340/685 49.6% 1/441 0.2% 2/234 0.9% 0/94 0% 0/58 0%IV 68/685 9.9% 1/441 0.2% 1/234 0.4% 0/94 0% 0/58 0%

MISSING 6/685 0.9% 5/441 1.1% 4/234 1.7% 2/94 2.1% 0/58 0%Mitral Valve Replacement, N=280

I 0/280 0% 165/192 85.9% 80/103 77.7% 33/42 78.6% 28/34 82.4%II 74/280 26.4% 21/192 10.9% 19/103 18.4% 8/42 19.0% 5/34 14.7%III 155/280 55.4% 3/192 1.6% 3/103 2.9% 1/42 2.4% 1/34 2.9%IV 45/280 16.1% 0/192 0% 0/103 0% 0/42 0% 0/34 0%

MISSING 6/280 2.1% 2/192 1.6% 1/103 1.0% 0/42 0% 0/34 0%


Note: N = all values reported; n = number in subgroup

Table 20. Late Effectiveness Outcomes — Hemodynamics, Valvular Regurgitation; Additional Data on16/19 mm Aortic and 24/27 mm Mitral Valves

Valve Size(mm)

No Regurgita-tion

% patients, n/N


% patients, n/N

Mild Regurgita-tion

% patients, n/N


% patients, n/N



16/19 mm 20%, 2/10 80%, 8/10 0%, 0/10 0%, 0/10 0%, 0/10Mitral Valves, N=10

24/27 mm 44.4%, 4/9 55.5%, 5/9 0%, 0/9 0%, 0/9 0%, 0/9


Table 21. Late Effectiveness Outcomes — Hemodynamics, Valvular Regurgitation; Original Patient Cohortand Additional Data on 16/19 mm Aortic and 24/27 mm Mitral Valves

Valve Size(mm)

No Regurgita-tion

% patients, n/N


% patients, n/N

Mild Regurgita-tion

% patients, n/N


% patients, n/N



16/19 mm 26.3%, 5/19 73.7%, 14/19 0%, 0/19 0%, 0/19 0%, 0/19Mitral Valves, N=290

24/27 mm 60%, 9/15 40%, 6/15 0%, 0/15 0%, 0/15 0%, 0/15


Table 22. Effectiveness Outcomes — Hemodynamics, Mean Pressure Gradient and Effective OrificeArea — Additional Data on 16/19 mm Aortic and 24/27 mm Mitral Valves

Endpoint Early Laten/N, mean ± SD (min, max) n/N, mean ± SD (min, max)


16/19 mm 9/10, 24.3 ± 11.2 (10.5, 49.0) 9/10, 26.8 ± 5.5 (18.8, 34.0)Effective Orifice Area (cm2)

16/19 mm 7/10, 1.1 ± 0.3 (0.8, 1.5) 9/10, 1.1 ± 0.3 (0.8, 1.9)Mitral Valve Replacement, N=10

Mean Gradient (mm Hg)24/27 mm 8/10, 4.3 ± 1.8 (2.4, 7.9) 9/10, 3.6 ± 0.9 (2.0, 5.2)

Effective Orifice Area (cm2)24/27 mm 9/10, 3.3 ± 0.8 (1.8, 4.7) 10/10, 3.4 ± 0.7 (2.5, 4.3)

Notes:1. Early postoperative evaluation conducted at 30 days postimplantation or hospital discharge.2. Late postoperative evaluation = 11 to 14 months postimplantation3. N = all values reported; n = number in subgroup

Table 23. Effectiveness Outcomes — Hemodynamics, Mean Pressure Gradient and Effective OrificeArea — Original Patient Cohort and Additional Data on 16/19 mm Aortic and 24/27 mm Mitral Valves

Endpoint Early Laten/N, mean ± SD (min, max) n/N, mean ± SD (min, max)


16/19 mm 19/23, 25.2 ± 9.6 (10.5, 49.0) 17/23, 23.3 ± 6.2 (13.0, 34.0)Effective Orifice Area (cm2)

16/19 mm 19/23, 1.1 ± 0.3 (0.7, 1.8) 17/23, 1.1 ± 0.4 (0.5, 1.9)Mitral Valve Replacement, N=23

Mean Gradient (mm Hg)24/27 mm 18/23, 4.4 ± 1.7 (2.3, 7.9) 17/23, 4.0 ± 1.2 (2.0,6.2)Effective Orifice Area (cm2)24/27 mm 9/23, 3.4 ± 0.8 (1.8, 5.2) 18/23, 3.2 ± 1.0 (1.6, 5.7)

Notes:1. Early postoperative evaluation conducted at 30-days postimplantation or hospital discharge.2. Late postoperative evaluation = 11–14 months postimplantation


3. N = all values reported; n = number in subgroup

7.3. Additional Clinical Data on Size 22/25 mm Mitral ValveAdditional data were obtained through September 2005 for patients implanted with the Medtronic OpenPivot 22/25 mm mitral heart valve. A total of 22 patients with a 22/25 mm mitral valve from 7 centers wereadded to the previously approved cohort.The 22/25 mm mitral heart valve patient cohort includes 22 patients. Cumulative follow-up was 106 pt-yrswith mean follow-up of 4.8 ± 3.3 yrs (0.003 – 9.8 yrs). Table 24 presents the patient demographicdata. Table 25 represents the change in NYHA classification. Table 26 presents adverse eventrates. Table 27, Table 28, and Table 29 present the hemodynamic results.

Results:

Table 24. Preoperative Patient Demographics: 22/25 mm Mitral (N=22): 106 Pt Yrs

Variable Category n % (n/N)Age at Implant (Years) 0-9 0 0.0%

10-19 0 0.0%20-29 1 4.5%30-39 7 31.8%40-49 1 4.5%50-59 2 9.1%60-69 6 27.3%70-79 4 18.2%80 & over 0 0.0%Not Reported 1 4.5%

Gender Female 18 81.8%Male 3 13.6%Not Reported 1 4.5%

Etiology Stenosis 5 22.7%Insufficiency 10 45.5%Mixed 6 27.3%Other 1 4.5%Not Reported 0 0.0%

Table 25. Effectiveness Outcomes: New York Heart Association (NYHA) Classification

22/25 mm Mitral Pre-Op 1 YearCLASS I (N)% of Total

00%

840%

CLASS II (N)% of Total

210%

630%

CLASS III (N)% of Total

1365%

15%

CLASS IV (N)% of Total

315%

00%

Undetermined (N)% of Total

15%

00%

Missing (N)% of Total

15%

525%

Table 26. Adverse Event Rates

22/25 mm Mitral Early Events% of pts (N)

Late Events%/pt-yrs (N)

Actuarial Freedom by Kaplan-Meier1 Year [95% CI] 5 Years [95% CI]

Death (all causes) 4.55% (1) 0.94% ± 0.10% (1) 0.9545 [±.09] 0.8909 [±.14]Death (valve-rela-ted/unexplained)

0.00% (0) 0.00% ± 0.00% (0) 1.000 [±.00] 1.000 [±.00]

Anticoagulant-Rela-ted Hemorrhage(All)

4.55% (1) 0.00% ± 0.00% (0) 0.9500 [±.10] 0.9500 [±.10]

Anticoagulant-Rela-ted Hemorrhage(Major)

4.55% (1) 0.00% ± 0.00% (0) 0.9500 [±.10] 0.9500 [±.10]

Thromboembolism(All)

4.55% (1) 0.95% ± 0.66% (1) 0.9524 [±.10] 0.8964 [±.14]

Permanent Neuro-logical Events

0.00% (0) 0.00% ± 0.00% (0) 1.000 [±.00] 1.000 [±.00]

Transient Neuro-logical Events

4.55% (1) 0.95% ± 0.58% (1) 0.9524 [±.10] 0.8964 [±.14]

Valve Thrombosis 0.00% (0) 0.95% ± 0.19% (1) 1.000 [±.00] 0.8889 [±.21]


22/25 mm Mitral Early Events% of pts (N)

Late Events%/pt-yrs (N)

Actuarial Freedom by Kaplan-Meier1 Year [95% CI] 5 Years [95% CI]

Perivalvular Leak(All)

0.00% (0) 0.00% ± 0.00% (0) 1.000 [±.00] 1.000 [±.00]


0.00% (0) 0.00% ± 0.00% (0) 1.000 [±.00] 1.000 [±.01]

Endocarditis 0.00% (0) 0.00% ± 0.00% (0) 1.000 [±.00] 1.000 [±.00]Hemolysis 0.00% (0) 0.00% ± 0.00% (0) 1.000 [±.00] 1.000 [±.00]Structural Dysfunc-tion

0.00% (0) 0.00% ± 0.00% (0) 1.000 [±.00] 1.000 [±.00]

Nonstructural Dys-function

0.00% (0) 0.00% ± 0.00% (0) 1.000 [±.00] 1.000 [±.00]

Reoperation 0.00% (0) 0.00% ± 0.00% (0) 1.000 [±.01] 1.000 [±.01]Explant 0.00% (0) 0.00% ± 0.00% (0) 1.000 [±.00] 1.000 [±.00]

Notes:1. N=22, Cumulative F/U = 106 pt yrs2. Cumulative probability of freedom from event estimate at the end of the interval (Pc) is based on the

Kaplan-Meier method.3. The 95% confidence interval bound for the cumulative freedom rate at the end of the interval =

1.96 X SE, where SE is the standard error estimate of the cumulative probability.

Table 27. Hemodynamic Data, Mean Gradient

Discharge Echo 22/25 mm MitralN 3Mean (SD) 6.2 (3.3)

Late Echo (>11 mos.) 22/25 mm MitralN 19Mean (SD) 4.7 (1.7)

Mean Follow-up: Mitral: 4.8 ± 3.3 years; Cumulative Follow-up: 106 pt yrs

Table 28. Hemodynamic Data, Effective Orifice Area

Discharge Echo 22/25 mm MitralN 2Mean (SD) 2.4 (1.1)

Late Echo (>11 mos.) 22/25 mm MitralN 15Mean (SD) 2.3 (0.7)

Mean Follow-up: Mitral: 4.8 ± 3.3 years; Cumulative Follow-up: 106 pt yrs

Table 29. Hemodynamic Data, Valvular Regurgitation

22/25 mm Mitral Early LateNo Regurgitation 5%

1/2025.0%5/20

Trivial Regurgitation 5%1/20

25.0%5/20

Mild Regurgitation 0.0%0/20

0.0%0/20

Moderate Regurgitation 0.0%0/20

0.0%0/20

Severe Regurgitation 0.0%0/20

0.0%0/20

Missing 90%18/20

50.0%10/20

8. Postoperative Information

8.1. MRI Safety Information Nonclinical testing and modeling has demonstrated that the Medtronic Open Pivot heart valve(Models 500, 501, and 505) is MR conditional. A patient with this device can be safely scanned in an MRsystem meeting the following conditions:■ static magnetic field of 1.5 T and 3 T■ maximum spatial gradient magnetic field of 2500 gauss/cm (25 T/m)■ maximum MR system reported, whole body averaged specific absorption rate (SAR) of ≤ 2.0 W/kg

(Normal Operating Mode)Based on nonclinical testing and modeling, under the scan conditions defined above, the Medtronic OpenPivot heart valve is expected to produce a maximum in vivo temperature rise of less than 1.8°C after15 minutes of continuous scanning.


Models 500 and 501:In nonclinical testing, the image artifact caused by the device extends no greater than 7 mm from theMedtronic Open Pivot heart valve for a spin echo pulse sequence and 15 mm for a gradient echo pulsesequence when imaged with a 3.0 T MRI system.

Model 505:In nonclinical testing, the image artifact caused by the device extends no greater than 13 mm from theMedtronic Open Pivot heart valve for a spin echo pulse sequence and 30 mm for a gradient echo pulsesequence when imaged with a 3.0 T MRI system.

9. Individualization of TreatmentAdequate anticoagulant and/or antiplatelet therapy should be administered. Selection of an anticoagulantand/or antiplatelet regimen is based on the particular needs of the patient and the clinical situation.

9.1. Specific Patient PopulationsThe safety and effectiveness of the Medtronic Open Pivot heart valve has not been established for thefollowing specific populations because it has not been studied in these populations:■ patients who are pregnant■ nursing mothers■ patients with chronic endocarditis■ patients requiring pulmonic or tricuspid replacementThere was limited use of the valve in patients requiring double or multiple valve replacement.

10. Patient Counseling Information■ Patients with prosthetic valves who undergo dental or potentially bacteremic procedures should

receive antibiotic prophylaxis.■ All mechanical prosthetic heart valves produce sound as a function of their operation. Patients should

be advised of this prior to implantation.■ Patients require anticoagulation and/or antiplatelet therapy.■ Patients should be encouraged to carry the Implanted Device Identification Card, provided by

Medtronic, with them at all times.

11. How Supplied11.1. PackagingThe outer carton label serves as a tamper-resistant package seal. Medtronic Open Pivot heart valves arepackaged and steam sterilized in transparent double barrier trays (Figure 4). Examine the trays carefully toverify that the seals and trays are intact. Do not use the valve if any seal is damaged or missing. Eachpackage is supplied sterile with a valve premounted onto a valve holder, a handle rotator, and a leafletactuator. The valve, valve holder, handle rotator, and leaflet actuator are ready for use when receivedunless the package sterility has been compromised or the Use-By Date has occurred.All package labeling and handle rotator accessories are color-coded and marked:■ Aortic – Green■ Mitral – RedThe Medtronic Open Pivot heart valve sizers are supplied nonsterile, and must be cleaned and sterilizedprior to use. The valve sizers are available to the implanting surgeon as an aid in selecting the appropriateprosthesis size. Each set of sizers is packaged with Instructions for Use specific to the sizer.The actuator is available for testing valve leaflet motion.All packaging material is recyclable. Manage disposal in accordance with local statutory regulations.

11.2. Handling and Storage (Packaged Valve)Care must be taken to ensure proper handling of the valve package during receiving, handling, andstorage.Upon receipt of product, visually inspect the outer package for possible damage.If evidence of damage is found, do not use.For maximum protection and product identification, it is recommended that the valve be stored in itsoriginal packaging. The storage environment should be clean, cool, and dry. The sterility andnonpyrogenicity of the valve is validated to remain unaffected until the Use-By Date printed on the product,provided the seals and containers are not opened or damaged.

11.3. Returned Product InformationFor detailed information on the Medtronic returned product policy, please contact your local representative.

11.4. Return of Explanted Prosthetic ValvesMedtronic is interested in obtaining recovered clinical specimens of the Medtronic Open Pivot heart valve.Specific studies of the explant may be performed and a written report summarizing the findings will bereturned to the implanting physician. Please contact Medtronic to obtain a Returned Material Authorization(RMA). The explanted valve should be completely submersed in a 2% to 5% formalin solution immediatelyafter excision unless otherwise directed by your Medtronic representative.

12. AccessoriesRefer to the Medtronic Open Pivot heart valve accessories Instructions for Use for cleaning instructions.


12.1. SizersA complete set of Medtronic Open Pivot™ heart valve sizers must be cleaned and sterilized prior tosurgery and made available in the operating room. Refer to the Medtronic Open Pivot heart valveaccessories Instructions for Use for cleaning and sterilization guidelines.Use only Medtronic Open Pivot heart valve sizers to measure the patient’s tissue annulus. The MedtronicOpen Pivot heart valve sizers have a metal shaft that can be shaped allowing the same sizer to be usedfor mitral or aortic tissue annulus measurement.The sizer with the diameter marked in millimeters has a clear plastic ring that allows for easy tissueannulus measurement. The sizer should pass easily through the patient’s tissue annulus with minimalresistance. Do not force the sizer through the tissue annulus. Valve oversizing or undersizing should beavoided.Caution: Oversizing may cause complications including tissue interference with leaflet motion or improperseating resulting in perivalvular leaks. Oversizing in the aortic position may result in blockage of thecoronary ostia. Undersizing may result in increased perivalvular leaks.

12.2. Standard Valve Sizing–White Handled SizerThe white-handled sizer must be used for sizing of the Medtronic Open Pivot heart valve standard models.The same Medtronic Open Pivot™ heart valve sizer set may be used for aortic or mitral sizing for standardvalves. The nominal diameter of the sizer in millimeters is printed onto the handle. The sizer selectedshould pass easily through the patient’s annulus without resistance but still provide a snug fit between thesizer ring and the tissue annulus.

12.3. AP Series Valve Sizing–Blue Handled SizerThe Medtronic Open Pivot AP series heart valve sizers are intended to simulate supra-annular placementof aortic or mitral valves. The blue-handled sizer must be used for sizing of the Medtronic Open PivotAP series heart valves. The AP series blue-handled sizer has 2 ring-shaped sizers. One end of the sizerconsists of a cylindrical ring used for measuring the tissue annulus. This end should pass easily throughthe patient’s annulus without resistance, but provide a snug fit. The other sizer end consists of a cylindricalring (of the same diameter as the opposing ring) with a rounded protruding edge that simulates the supra-annular cuff of the AP series heart valves, and can be used to estimate the diameter and height of thesupra-annular cuff of the AP series heart valves.The center of the sizer ring is open so that the native annulus beyond the sizer ring can be examined forintruding tissue that might touch the valve leaflets. Any intruding tissue should be removed. If it is notpossible to remove the intruding tissue or rotate the valve and position the leaflets to avoid leafletinterference, a smaller size valve should be selected, sized, and evaluated in the same manner asdescribed above.

12.4. Valve Holder and Handle RotatorThe valve is mounted on a disposable holder that is attached to a color-coded handle rotator (green isaortic; red is mitral). The rotator is used to rotate the valve in situ. The blood flow in either the aortic ormitral position is always into the straight edge of the leaflets.

12.5. Bendable HandleThe bendable handle can be attached to the holder instead of the handle rotator assembly during use. Thehandle has a metal shaft that can be easily shaped to provide access to the aortic or mitral annulus.

13. Patient Information13.1. Registration InformationNote: Patient registration does not apply in countries where patient privacy laws conflict with providingpatient information, including countries from the European Union. A patient registration form is included ineach device package. After implantation, please complete all requested information. The serial numbermay be found on the tray and box labels. Return the original form to the Medtronic address indicated onthe form, and provide the temporary identification card to the patient prior to discharge.An Implanted Device Identification Card is provided to the patient. The card contains the name andtelephone number of the patient’s physician, as well as information that medical personnel would requirein the event of an emergency.

13.2. Patient Information BookletMedtronic has made available a Patient Information Booklet that the physician may choose to provide tothe patient prior to discharge. Copies of this booklet are available on request from your local salesrepresentative.

14. Disclaimer of WarrantyTHE FOLLOWING DISCLAIMER OF WARRANTY APPLIES TO UNITED STATES CUSTOMERS ONLY:

ALTHOUGH THE MEDTRONIC OPEN PIVOT HEART VALVE, HEREAFTER REFERRED TO AS“PRODUCT,” HAS BEEN MANUFACTURED UNDER CAREFULLY CONTROLLED CONDITIONS,MEDTRONIC HAS NO CONTROL OVER THE CONDITIONS UNDER WHICH THIS PRODUCT ISUSED. MEDTRONIC, THEREFORE, DISCLAIMS ALL WARRANTIES, BOTH EXPRESS AND IMPLIED,WITH RESPECT TO THE PRODUCT, INCLUDING, BUT NOT LIMITED TO, ANY IMPLIED WARRANTYOF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. MEDTRONIC SHALL NOT BELIABLE TO ANY PERSON OR ENTITY FOR ANY MEDICAL EXPENSES OR ANY DIRECT,INCIDENTAL, OR CONSEQUENTIAL DAMAGES CAUSED BY ANY USE, DEFECT, FAILURE, ORMALFUNCTION OF THE PRODUCT, WHETHER A CLAIM FOR SUCH DAMAGES IS BASED UPON


WARRANTY, CONTRACT, TORT, OR OTHERWISE. NO PERSON HAS ANY AUTHORITY TO BINDMEDTRONIC TO ANY REPRESENTATION OR WARRANTY WITH RESPECT TO THE PRODUCT.

The exclusions and limitations set out above are not intended to, and should not be construed so as tocontravene mandatory provisions of applicable law. If any part or term of this DISCLAIMER OFWARRANTY is held to be illegal, unenforceable, or in conflict with applicable law by a court of competentjurisdiction, the validity of the remaining portions of this DISCLAIMER OF WARRANTY shall not beaffected, and all rights and obligations shall be construed and enforced as if this DISCLAIMER OFWARRANTY did not contain the particular part or term held to be invalid.

Authorized Representative in the EuropeanCommunityMedtronic B.V.Earl Bakkenstraat 106422 PJ HeerlenThe NetherlandsTel. +31 45 566 8000AustraliaMedtronic Australasia Pty. Ltd.5 Alma RoadMacquarie Park, NSW 2113Australia1800 668 670CanadaMedtronic of Canada Ltd.99 Hereford StreetBrampton, Ontario L6Y 0R3CanadaTel. +1 905 460 3800Toll-free: +1 800 268 5346

United StatesManufacturer:Medtronic, Inc.710 Medtronic ParkwayMinneapolis, MN 55432USAInternet: www.medtronic.comTel. +1 763 526 7890Toll-free: +1 877 526 7890(24-hour consultation service)

Manufactured InMedtronic, Inc.3800 Annapolis LaneMinneapolis, MN 55447USA

*M951905A002*

© 2013, 2016 Medtronic, Inc.M951905A002 Rev. 1A

Date post:	19-Mar-2023
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