Indicated for Arterial and Venous Embolizations in the Peripheral Vasculature

April, 2004

Vascular PlugVascular Plug

Device DescriptionA self-expandable, cylindrical device made from a Nitinol wire mesh.

Secured on both ends with platinum/iridium marker bands.

A stainless steel microscrew is welded to one of the platinum/iridium marker bands, which allows attachment to the 135 cm long stainless steel delivery cable.

AMPLATZER® Vascular Plug

1

Vascular PlugVascular Plug

The AMPLATZER Vascular Plug is Indicated for

Arterial and Venous Embolizations in the

Peripheral Vasculature

 Warning: The safety and effectiveness of this device for cardiac

(for example, patent ductus arteriosus or paravalvular leak closures)

and neurological uses have not been established.

Intended Use:

2

Vascular PlugVascular Plug

The AMPLATZER Vascular Plugs are made in various sizes ranging from 4 to 16 mm in 2 millimeter increments.

3

Vascular PlugVascular Plug

PackagingThe Plug is pre-loadedAttached to 135 cm delivery cable

Packaged in a hoop dispenser

4

Package LabelingPackage Labeling

5

Vascular PlugVascular Plug

Contraindications & Potential Adverse EventsContraindicationsNone known.

Potential Adverse EventsPossible complications include, but are not limited to:Hemotoma at the site of entry, vessel perforation, or embolization of the device.

6

Vascular PlugVascular Plug

Order No.AMPLATZERVascular Plug

DiameterDevice Length

Catheter Requirements*

Minimum Size Minimum IDMaximum

Length

9-PLUG-004 4 mm 7 mm 5 French .056” 100 cm

9-PLUG-006 6 mm 7 mm 5 French .056” 100 cm

9-PLUG-008 8 mm 7 mm 5 French .056” 100 cm

9-PLUG-010 10 mm 7 mm 6 French .067” 100 cm

9-PLUG-012 12 mm 8 mm 6 French .067” 100 cm

9-PLUG-014 14 mm 8 mm 8 French .088” 100 cm

9-PLUG-016 16 mm 8 mm 8 French .088” 100 cm

Product Specifications and Ordering Information

* For use with standard guiding catheters meeting minimum internal diameter requirements.

7

Sizing and Device SelectionSizing and Device Selection

Perform an angiogram and measure the diameter of the vessel.

Select a device approximately 30 – 50% larger than the vessel diameter.

8

Vascular PlugVascular Plug

Directions For UseFlush the loader through its hoop to purge air from the loader (shown).

Remove the white hub clip (at arrow) and pull the delivery cable with the preloaded AMPLATZER Vascular Plug from the hoop.

9

Vascular PlugVascular Plug

1.

2.

Insert and advance the selected guidingcatheter to the target vessel.

Insert the loader through the hemostasis valve and advance until it contacts the hub of the catheter Figure 1.

Loading and Advancement to the Target

10

Figure 1

Vascular PlugVascular Plug

3.

4.

Advance the AMPLATZER Vascular Plug from the loader into the catheter to the target vessel. Figure 2.

Remove the loader if desired. Figure 3.

Loading and Advancement to the Target - Continued

11

Figure 2

Figure 3

Vascular PlugVascular Plug

Device PlacementVerify correct position of the AMPLATZER Vascular Plug with a test injection through the catheter. If device position is unsatisfactory, the device can be repositioned or removed together with the catheter.

If device position is satisfactory, release the device by rotating the delivery cable in a counter clockwise fashion (shown on next page).

More than one AMPLATZER Vascular Plug may be required to achieve occlusion of a vessel.

12

Vascular PlugVascular Plug

If detachment is difficult, a torque device or surgical clamp may be used to assist with the release of the device by rotating the delivery cable in a counter clockwise fashion.

13

Vascular PlugVascular Plug

Figure A: large lower lobe to pulmonary vein fistula with large feeding vessels

Courtesy J. P. Cheatham, M.D., Sharon L. Hill, MSN, ACNP

Figure B: smaller feeder vessels from medial and lateral fistula tracts

Courtesy J. P. Cheatham, M.D., Sharon L. Hill, MSN, ACNP

14

Vascular PlugVascular Plug

Figure C: Three 8 mm Vascular Plugs implanted

Courtesy J. P. Cheatham, M.D., Sharon L. Hill, MSN, ACNP

Figure D: No residual flow through large fistula

Courtesy J. P. Cheatham, M.D., Sharon L. Hill, MSN, ACNP

15

Vascular PlugVascular Plug

16

Contrast injection to identify collaterals off of the descending aorta targeted for embolization.

Courtesy Ziyad M. Hijazi, M.D.

Vascular PlugVascular Plug

17

Contrast injection confirming complete closure of two of the targeted vessels.

Courtesy Ziyad M. Hijazi, M.D.

Vascular PlugVascular Plug

18

AMPLATZER Vascular Plug embolization.

Courtesy Ziyad M. Hijazi, M.D.