LiveNova Health innovation that matter s FIELD SAFETY NOTICE Perceval Sutureless Heart Valve manufactured by Sorin Group Italia S.r.l. and LivaNova Canada Corp. Affected Devices: Perceval Sutu reless Heart Va lve DRAFT Date: XX August 2016 Reference No: FSCA-HV-2016-001 Attention: Risk I Safety Managers, Distributors, Clinicians and ot her users of these devices Reason: Clarification for implantation instructions Type of action: Advice given by the Manufacturer rega rding the use of the device Dear Valued Cust ome r, This comm uni cat ion is intended to provide you wit h some clarifications about the im plant of the Perceval sutureless aortic valve and to bring your attention on some steps that may influence procedural success and potential comp lications. Perceval is a bioprosthetic valve designed to rep lace a diseased nat ive or a malfunctioning prost hetic aortic valve via open heart surgery, with the unique characte ristic of allow ing sut ur eless positioning and anchoring at the implant site. The prosthesis is indicated for u se in adult patients who are diagnosed to have ao rtic valve stenosis or steno -insuff iciency. Being an innovative device whose implant technique differs from that of the most common sutured aortic valve prostheses, Perceval implantation shall be performed only by physician and associated staff trained in the specific steps for preparation and implantation by successful completion of our dedicated proetaring program for Perceval. In addition to the Instructions for Use accompanying each device, an "Inservice Guide" with a detailed and ill ustrated description of the valve preparation and impl antatio n steps is provided as training material. Since initial market introduction of the Perceval valve, LivaNova has continued to gather feedback from users regarding critical procedural steps requiring careful execution in order to reduce the possibility of intraoperative complications, such as val ve malpositioning, significant perivalvular or central regurgitation and permanent pacemaker implantation. Li vaNova is therefore providing clarifications on the se implantat ions steps in order to integrate inf ormat ion addressed in the Instructions for Use and the In service Guide. LivaNova is comm itted to providing quality products and service to i ts customers and we rely on your col laborat ion for the correct application of the material provided in the attached document. Sorin Group ltall a S.r.l. a wholly-owned subsldlary or Ll vaNova Pfc Scde Le gale: Via ßenigno Crespi, 17 - 20159 Nllano - Italy Sede Amminlstratlva: VIa Statale 12 Nord , 86 - 41037 Mlrandola lta\y Te\.+39 0535 29811 Fax +39 0535 25229 Stabl\lmentl: Via Statale 12 Nord , 86 - 41037 llaly Tel.+39 0535 29811 F ax +39 0535 25229 VIa Crescentino sn - 13040 Saluggla (VCJ ltaly Tel.+39 0161 487.1 Fax +39 0161487.681 Viale Cesare Cattaneo, 20 - 22063 Cantü (CO) Italy Tel.+39 031 7370411 Fax +39 031 7370410 Scdl Commerclall : VIa Statale 12 Nord, 86- 41037 Mlrandola (MO) Italy Tel.+39 0535 29811 Fax +39 0 535 25229 Via Benigne Crespl, 17 - 20159 Italy Tel.•·39 02 69165.211 - Fax +39 02 69465.300 S ervlzlo Cll entl Italla: +39 02 37014960 Inte rnational Customer Service: +39 02 37027030 Socletä soggetta all'attlvitä dl dlrezione e coordinamento dil parte della capogruppo LlvaNova Pie capltale So clale: C 8.550.034,00 Registro Imprese dl N. 10556980158 R.E.A. 1767776- Imp./Exp. 352423 Cod. Flsc. 10556960158 - Part. !VA 02109510368 ISO CODE IT02109510368 R eg lstro Nazianale Produttori AEE N. IT08020000000823 www llyanova.co ..m
Transcript
LiveNova Health innovation that matters
FIELD SAFETY NOTICE Perceval Sutureless Heart Valve
manufactured by Sorin Group Italia S.r.l. and LivaNova Canada Corp .
Affected Devices: Perceval Sutureless Heart Va lve DRAFT
Date: XX August 2016
Reference No: FSCA-HV-2016-001
Attention: Risk I Safety Managers, Distributors, Clinicians and other users of these devices
Reason: Clarificat ion for implantation instructions
Type of action: Advice given by the Manufacturer regarding the use of the device
Dear Va lued Cust omer,
This communication is intended to provide you with some clarifications about the implant of the Perceval sutureless aortic valve and to bring your attention on some steps that may influence procedural success and potential complications.
Perceval is a bioprosthetic valve designed to rep lace a diseased native or a malfunctioning prosthetic aortic valve via open heart surgery, with the unique characteristi c of allowing sutureless positioning and anchoring at the implant site. The prosthesis is indicated for use in adult patients who are diagnosed to have aortic valve stenosis or steno-insufficiency.
Being an innovative device whose implant technique differs from that of the most common sutured aortic va lve prostheses, Perceva l implantation shall be performed only by physician and associated staff trained in the specific steps for preparation and implantation by successful completion of our dedicated proetaring program for Perceval. In addition to the Instructions for Use accompanying each device, an "Inservice Guide" with a detailed and illustrated description of t he valve preparation and implantation steps is provided as training material.
Since initial market introduction of the Perceval valve, LivaNova has continued to gather feedback from users regarding critical procedural steps requiring carefu l execution in order to reduce the possibility of intraoperative complications, such as va lve malpositioning, sign ificant perivalvular or central regurgitation and permanent pacemaker implantation. Li vaNova is therefore providing clarifications on these implantations steps in order to integrate information addressed in the Instructions for Use and the Inserv ice Guide.
LivaNova is committed to providing quality products and service to its customers and we rely on your col laboration fo r the correct application of the material provided in the attached document.
Sorin Group ltalla S.r.l. a wholly-owned subsldlary or LlvaNova Pfc
Note: the Perceval Sutureless Heart Va lve affected by this Field Safety Notice are manufactured by:
Sorin Group Italia S.r.l. Via Crescentino, sn 13040 Saluggia (VC) - Italy
LivaNova Canada Corp. 5005 North Fraser Way Burnaby, BC V5J 5M1 CANADA
Action to be taken by the user of the device:
We recommend that you carefully review the information provided in the attached document (IM-00760 " Perceval implant key points") If you have additional questions or request of clarifications, please contact the reference person reported below, your LivaNova representat ive or Customer Service.
Transmission of this Field Safety Notice:
Piease assure within your organization that this notice is communicated to all personnel who need to be aware of thi s Field Safety Notice . In case you have transferred products to a third party please communicate this information to them and also indicate so on the Customer Response Form.
Piease maintain awareness of this notice and resulting action for an appropriate period to ensure effectiveness of the corrective action.
A copy of this Field Safety Notice has been provided to the appropriate Regulatory Agency who are aware of these actions.
Sorln Group Italla S.r.t. a wholly -owned subsidiary of livaNova Pie
Sede Legale: Via Benigne Crespi, 17 - 20159 Nllano - Italy Scde Ammlnlstrativa: Via Stata le 12 Nord, 86 -· 41037 ~Hrandola ( ~10) Italy Tel.+39 0 535 29811 Fax +39 0535 25229 S tabilimentl: Via Sta tale 12 Nord, 86 - 41037 Nlrandola (MO) Italy Tel.+39 0535 29811 Fax +39 0535 25229 Via Crescentino s n - 13040 Salugg la (VC) ltaly Tel.+39 0161487.1 Fax +39 0161 487 .68 1 Vlale Cesare Cattaneo, 20 - 22053 CantU (CO} Italy Tel.+39 0 31 7370411 Fax +39 031 7370410
Servizio Clienti Italia: +39 02 370 14960 International Customer Service : + 39 02 37027030
Societä soggctta all'a ttivitä di direz ione e coordioa men to da parte della capogruppo LlvaNova Pie
Ca pltale S oclale: C 8.550.034,00 Registro Imprese di Milano N. 10556980 158 R.E.A. MII.ANO 1767776 - N.Mecc. lmp./Exp. NI 352423 Cod. Fisc. 105569801 58 - Part . IVA 02109510368 ISO CODE !T02109510368 Reglstro Nazianale Produttori AEE N. I T08020000000823
www !lyaoova com
LiveNova Hea lth innovation that matters
Contact reference person:
For questions regarding this Field Safety Notice1 please contact Giovanni Gaviglio1 Director Qual ity Assurancer Phone: +39 (0) 161 48781 21 Fax: + 39 (0) 161 487599 1 Emai l : FSCA[email protected] or your Li vaNova sa les representative .
Liva Nova is commi tt ed t o prov ide qua lity products and serv ices to its cust omers and we apolog ize for any inconvenience t his Situation may cause.
Thank you for your cooperation in th is matter.
Sincerely1
Giovanni Gaviglio Director Quality Assurance
Sorin Group Italla S.r .l. a who ll y·owned subs idlary or livaNo va Pie Sede Legale: Via Benigno Crespi, 17- 20159 Nllano- Itaiy Sede Ammlnlstra tlva: Via Stataie 12 Nord, 85- 41037 ~11randola ( ~10) Itaiy Tel.+39 0535 29811 Fax +39 0535 25229 S t abll im entl : Via Statale 12 Nord, 85 - 41037 ~llrandola (~10) Itaiy Tel.+39 0535 29811 Fax +39 0535 25229 Via Crescentino sn - 13040 Saluggia (VC) Itaiy Tel.+39 0151 487.1 Fax +39 0151 487.581 Viale Cesare Cattaneo, 20 - 22053 Cantü (CO) Italy Tel.+39 031 7370411 Fax +39 031 7370410
S edi Commercla ll : Via Stataie 12 Nord, 85 - 41037 ~11randoia ( ~10) Italy Tel.+39 0535 29811 Fax +39 0535 25229 Via Benlgno Crespl, 17- 20159 ~lllano- Itaiy Tel.+39 02 59455.211 .. Fax +39 02 69465.300
Servizio Cllenll Italla : +39 02 370 14960 I ntern o:tt lonal Customer Service: +39 02 37027030
Societä soggetta all'attlvitä dl direzione e coordinamento da parte della capogruppo llva Nova Pie
Capita ie Socla ie: C 8 .550.03 4,00 Registro lmprese dl ~lllano N. 10556980158 R.E.A. t·IIIJ\NO 1757775 - N .~1ecc. lmp./Exp. NI 352423 Cod. Fisc. 10555980158 - Part. !VA 02109510368 ISO CODE IT02109510368 Registro Naziona ie Produttorl AEE N. IT08020000000823
www.ljyanoya.com
LiveNova Health i nnovation that matters
Customer Response Form
FIELD SAFETY NOTICE: Reference # FSCA-HV-2016-001
According to our records your center is qualified fo r using the Perceval Sutureless Hea rt Valve.
Piease return this completed form to:
LivaNova subsidiary/ Distributor Name:
Country:
Contact Name:
E-mail:
Fax No .:
Phone Number:
Piease Complete:
<< Prin t Your Cornpany name here>>
< < Print Your Country here> >
< < Print Your Contact Name here> >
< < Print Your E-mail address here> >
< <Prin t Your Fax No. here> >
<< Pt int Your Phone No. here> >
1. WeHAVE reviewed and understand the FIELD SAFETY NOTICE o
2. Yes - We do have the listed affected products and we will follow t he indication o
3. We DO NOT have/use the subject products /or/ We request more information (please specify)
Piease contact us: Email : FSCA- HV@Iivanova .com
Customer Name: <<Prin t Your Cornpany narne here>>
Country : <<Prin t Your Country here>>
Contact Name : << Print You r Contacl Narne her·e>>
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Submitted by
Signature
Sorln Group Jtalla S.r.l. a wholly~owned subsidfary of LlvaNova Pie
WARNING: Checkthat at the preoperative echo the ratio between the sinotubular junction and the annulus diameter is < 1.3. A ratio greater than 1.3 indicates a condition of aortic root dilation for which Perceval S implant is contraindicated.
Transesophagea l echocardiography (TEE) provides information on the aortic root geometry allowing the measurement of the sinotubular junction (STJ) and the subsequent calculation of the STJ to annulus ratio, which should be < 1.3 for optimal seating of the va lve. Measurement of the sinotubular junction may be challenging without TEE.
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Perceval Out of the Jar
The valve as found in the jar does not coapt
completely. A symmetric shape can be seen, but the Ieaflets do not coapt.
That is normal, in fact, Perceval has a larger diameter than the indicated annuli range, in order to apply a radial force for valve sealing and anchoring once implanted.
When the valve is properly sized and implanted, its inflow diameter is reduced to fit the patient's annulus and obtain Ieaflet coaptation.
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Aortotomy
A transverse aortotomy located at least 3. 5 cm above the aortic annulus or at least 0. 5 cm above the sinotubular junction is considered optimal.
WARNING: Oblique aortotomy is not recommended since release of the device at the implant might result in aortotomy suture difficulties.
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The aortotomy is made transversely, higher than what is used for traditional AVR. The reason is that the Nitinol stent is Ionger than a traditional valve and the outflow portion could interfere with the closure of the aortotomy or may be caught within the suture if the aortotomy is too low.
Aortotomy extension depends on the surgeon's preference; it is not recommended to overextend the incision.
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Perceval implant related precautions
In case of concomitant procedures these must be performed as much as possible prior to Perceval S implantation.
After Perceva l implantation, manipulation of the heart and/or of the ascending aorta, if required, should be done gently; should an atrial retractor be placed, take care not to compress the ascending aorta. These manoeuvres may Iead to unknown effects on the implanted valve, including displacement and folding.
LivaNova IM-00760 8
Decalcification
Warning: Complete intra-annular decalcification of the annulus is not necessary, but eccentric/bulky protruding intra-luminal calcifications must be removed.
Inadequate decalcification or residual calcium may cause an uneven surface that can Iead to
paravalvular leakage.
Bulky calcium deposits in the LVOT might prevent optimal expansion of the inflow portion of the stent. These deposits should be addressed during the implant to avoid PVL and/or incorrect valve positioning .
LVOT hypertrophy may prevent optimal expansion of the inflow portion of the stent. In this case myectomy is recommended
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Deca lcification
Decalcification is very important in the areas close to the commissures.
Here the ca lcium deposits cou ld impair the comm issura l strut expansion.
Collar Seating
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Sizing
Each sizer represents the lower and upper Iimits of the Perceval va lve's respective size.
It is recommended to start the sizing with the "S" sizer.
White Obturators should not deform the annulus during t he sizing procedure. Avoid forcing the white obturator through the annulus.
The importance of correct sizing
The appropriate size of the prosthesis is established when the transparent Obturator passes easily through the aortic annulus into the left ventricle, and the white obturator remains stable above the aortic annulus
Undersizing may Iead to centra l or paravalvular leakage, while oversizing may Iead to elevated pressure gradients or valve malfunction.
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Cerreet size
Proceed with next sizer
11
Sizing: what to do in case of doubt?
Examp/e : if you push with additional force, the white obturator will pass through the annulus
Suggestion: verify that the valve sizer has entered into the annulus perpendicular to the annular plane.
Then, if white obturator remains above the annulus or blocked within the annulus requiring firm traction for retrieval, choose the same size valve (not the larger size).
REMEMBER :
There is no advantage in Perceval oversizing.
An oversized Perceval valve will not guarantee better hemodynamic performance. If oversized, Perceval will likely showsuboptimal expansion which could result in higher gradients.
TIP : In a border line case, with the annulus right in between two sizes, consider the overall dimension of the aortic root (sinuses and STJ width) for your size choice.
LiveNova IM-00760 12
Guiding Sutures
Correct placement of the guiding sutures is key to the correct positioning of the valve.
Guiding sutures must be placed to hold the traction applied during the implantation of the device.
Position a guiding suture in each valve sinus, 2- 3 mm under the Ieafiet hinge point, perpendicular to the annulus.
The 120 degree distribution of the sutures can be ensured by using the sizers, as they have reference spokes which are distributed at 120 degrees.
LiveNova IM -00760
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Guiding Sutures - LVOT Extremity Guidelines
Avoid placing the guiding sutures too low in the annulus.
The LVOT extremity should not be more than 2-3 mm below the annulus.
The collar of the Perceval inflow should seat above the annulus.
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annulus
The L VOT extremities of the guiding sutures determine the depth of the valve.
Therefore, it is important that the guiding sutures are p/aced by inserting the needle in the LVOT (be/ow the annulus) and exiting above the annulus.
This prevents the valve from being deployed too low or too high in the aortic root.
LivaNova IM-00760 14
Guiding Sutures - Aortic Extremity Guidelines
The aortic extremity of the guiding sutures provide an important reference point prior to valve deployment.
Place the guiding sutures with aortic extremity Ievei at 2-3 mm above the annulus. This will provide a good reference for the positioning of the valve before the opening of the inflow.
The rim of the collar should be at approximately the same Ievei of the exit point of the guiding sutures.
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Traction Sutures
The use of traction sutures, placed at Ievei of the commissures, is not mandatory in Perceval implantation.
However, their use may help visualization and facilitate the positioning of the guiding sutures.
If using traction sutures, remember to release the traction sutures prior to valve deployment.
As traction sutures Iift the annulus plane upwards, they should be released prior to Perceval implantation to avoid misplacement of the valve after their release.
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Surgical Technique - Traction of the Guiding Sutures
All three guiding sutures must be pul led firmly during valve deployment.
If tension is weak on one of the guiding sutures, the va lve could tilt to that side.
The guiding sutures should be pul led at a narrow angle close to the holder.
Ensure that during valve deployment, you are not preventing your assistants from keeping a/1 three guiding sutures properly pulled at the correct angle.
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Valve Deployment
Assess valve alignment from the left, right and non coronary sinus. As the nadir of the non coronary cusp is lower, the holder should be tilted toward the surgeon to ensure appropriate seating of the valve at the annular Ievei and prevent PVL.
Rotate the knob at the end of the holder clockwise (opened-lock arrow) until you hear a click and "feel" the valve inflow ring being released.
In this step, make sure you are not tilting the holder which must be kept perpendicular to the annular plane.
Ensure the sutures are not tangled araund the stent posts, which could interfere with the proper seating of the device.
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Va lve Deployment
Remove the Smart Clip and pull back the sliding sheath of the holder.
Avoid rotational movements and keep the Holder in an axial position with respect to the aorta.
Ensure that the guiding sutures are not trapped in the stent struts.
The outflow of the valve will be released following the withdrawal of the holder.
After deployment is complete, the holder should be removed from the LVOT with gentle rotational movements. Avoid tangling the holder in the prosthesis.
LiveNova IM-007 60 19
Ballooning
The balloon dilation provides optimal sealing of the valve to the aortic annulus.
The balloon dilation does not cause deformation of the stent.
Choose balloon that corresponds to the size of the valve to be implanted.
During the balloon dilation, the catheter must be kept absolutely steady to avoid misplacement or darnage to the prosthesis.
Ensure balloon is completely deflated before removing it (retrieving the balloon not fully deflated may cause va lve displacement).
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Inspection before closing the aorta
Before closing the aorta, the following checks should be performed:
• Coronary ostia patency
• Proper valve positioning
The pericardial sealing collar (C) shou ld sit supra annularly while the inflow skirt (A) should sit intra annularly.
LivaNova IM-00760
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21
Inspection before closing the aorta
Valve positioning :
The collar of the Perceval seats supra-annularly while the skirt of the inflow seats intra-annularly. Therefore, if the annulus is visible from the top,
the valve is placed too low. If the annulus is visible from the ventricular side, the valve is positioned too high.
Check visually that sinusoidal struts are juxtaposed at the Valsalva sinuses. Full apposition of the outflow ring to the aortic wall at the Ievei of the STJ is not required. Post-dilation of the outflow ring is not recommended.
LivaNova IM-00760 22
Inspection before closing the aorta
A Perceval valve properly sized and implanted into the aortic root will show an even coaptation, with the rims of the Ieaflets at the same height.
Note that the possible presence of a central limited space between the Ieaflet is intrinsic to the valve design, provided that is symmetrical and limited in extension .
Verify that the prosthesis is weil-anehered to the aortic root and that there is no Iack of contact between the prosthesis and aortic annulus, potentially responsible for Para-prosthetic leaks. Aortic root filling maybe done at the physician's discretion (hydraulic testing).
By delicately using rounded pliers, Ieaflets should show an even coaptation with the rims of the Ieaflets at the same height .
LivaNova IM-00760 23
Removal of the Guiding Sutures
Remave guiding sutures before closing the aortotomy.
To remove the guiding sutures, they must be cut right above the Ievel of the aortotomy.
The guiding sutures must not be tied. This may prevent optimal valve seating and cause central or paravalvular leaks.
LiveNova IM-00760 24
Potential risks due to tying of guiding sutures
Til ted va lve due to:
• improper gu iding sutures position ing in unfavorable anatomy
• misplacement during knotting
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Distorted valve due to improper guiding sutures placement (not aligned to the va lve eyelets, distributed at 120 degrees)
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Prosthesis Removal Procedure
Should it be necessary to remove the prosthesis from the implant site, proceed as follows:
Place crushed ice from a sterile physiological solution in the surgical area, ensuring that the ice comes into contact with the prosthesis;
Wet the prosthesis with the iced physiological solution and simultaneously clamp the outflow section of the prosthesis with three surgical forceps positioned at 120°;
Use the forceps to create radial compression on the prosthesis to reduce its diameter; the procedure is performed holding the superior portion of the stent (outflow) at two opposite points and dragging them to the center at the same time, forming an 'x' . Using the 'x-movement', the prosthesis can be easily removed (*).
After detachment of the prosthesis from the aortic wall, extract the forceps and prosthesis as if they were a single device, do not damage the surrounding tissue.
A removed Perceval prosthesis MUST NOT BE REIMPLANTED, as its integrity is no Ionger guaranteed.
(*) Santarpino G. et al. "A supra-annular malposition of the Pereeval S sutureless aortie valve: the 'x-movement' removal teehnique and subsequent reimplantation" Interaetive CardioVaseular and Thoraeie Surgery 15 (2012) 280-281
LivaNova IM-00760 26
Closing the aorta
Make sure the closing suture does not catch the stent by any means.
Since the Ievei of the aortotomy will move distally with respect to the annulus after declamping, catching the frame bears the risk of disiodging the valve into the aortic root.
Therefore, every stitch of the suture has to be carried out with visual inspection to ensure exact closure.
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Intraoperative post-implant Echo
Intraoperative post-implant echo is an important step for quality control in every valve procedure.
In the setting of sutureless implantation, it prevents late detection of device malfunction or regurgitation following the procedure.
Note: after declamping, especially in cases of low pressure, a trivial central leakage may be detected. This most likely disappears in a few hours once diastolic pressure is restored. If greater leakage is detected, check valve sizing and positioning to assess the need for valve explant.
