Indicated for Arterial and Venous Embolizations in the Peripheral Vasculature April, 2004

Vascular Plug Device Description A 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 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 Plug The AMPLATZER Vascular Plugs are made in various sizes ranging from 4 to 16 mm in 2 millimeter increments. 3

Vascular Plug Packaging The Plug is pre-loaded Attached to 135 cm delivery cable Packaged in a hoop dispenser 4

Package Labeling 5

Vascular Plug Contraindications & Potential Adverse Events Contraindications None known. Potential Adverse Events Possible complications include, but are not limited to: Hemotoma at the site of entry, vessel perforation, or embolization of the device. 6

Vascular Plug Order No. AMPLATZER Vascular Plug Diameter Device Length Catheter Requirements* Minimum SizeMinimum ID Maximum Length 9-PLUG-0044 mm7 mm5 French.056”100 cm 9-PLUG-0066 mm7 mm5 French.056”100 cm 9-PLUG-0088 mm7 mm5 French.056”100 cm 9-PLUG mm7 mm6 French.067”100 cm 9-PLUG mm8 mm6 French.067”100 cm 9-PLUG mm8 mm8 French.088”100 cm 9-PLUG mm8 mm8 French.088”100 cm Product Specifications and Ordering Information * For use with standard guiding catheters meeting minimum internal diameter requirements. 7

Sizing 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 Plug Directions For Use Flush 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 Plug Insert and advance the selected guiding catheter 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 Plug 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 Plug Device Placement Verify 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 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 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 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 Plug 16 Contrast injection to identify collaterals off of the descending aorta targeted for embolization. Courtesy Ziyad M. Hijazi, M.D.

Vascular Plug 17 Contrast injection confirming complete closure of two of the targeted vessels. Courtesy Ziyad M. Hijazi, M.D.

Vascular Plug 18 AMPLATZER Vascular Plug embolization. Courtesy Ziyad M. Hijazi, M.D.