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
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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:
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Vascular PlugVascular Plug
The AMPLATZER Vascular Plugs are made in various sizes ranging from 4 to 16 mm in 2 millimeter increments.
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Vascular PlugVascular Plug
PackagingThe Plug is pre-loadedAttached to 135 cm delivery cable
Packaged in a hoop dispenser
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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.
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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.
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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.
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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.
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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
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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
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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.
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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.
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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
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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
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Vascular PlugVascular Plug
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Contrast injection to identify collaterals off of the descending aorta targeted for embolization.
Courtesy Ziyad M. Hijazi, M.D.
Vascular PlugVascular Plug
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Contrast injection confirming complete closure of two of the targeted vessels.
Courtesy Ziyad M. Hijazi, M.D.