Indicated for Arterial and Venous Embolizations in the Peripheral Vasculature

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Indicated for Arterial and Venous Embolizations
in the Peripheral Vasculature
April, 2004
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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
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Vascular Plug
Intended Use

• 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.

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Vascular 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 Plug
Packaging
The Plug is pre-loaded
Attached to 135 cm delivery cable
Packaged in a hoop dispenser
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Package Labeling
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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.
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Vascular Plug
Product Specifications and Ordering Information
For use with standard guiding catheters meeting
minimum internal diameter requirements.
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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.

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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.
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Vascular Plug
Loading and Advancement to the Target
1.
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.
2.
Figure 1
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Vascular Plug
Loading and Advancement to the Target - Continued
3.
Advance the AMPLATZER Vascular Plug from the
loader into the catheter to the target vessel.
Figure 2. Remove the loader if desired. Figure 3.
4.
Figure 2
Figure 3
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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.
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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.
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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
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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
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Vascular Plug
Contrast injection to identify collaterals off of
the descending aorta targeted for
embolization. Courtesy Ziyad M. Hijazi, M.D.
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Vascular Plug
Contrast injection confirming complete closure of
two of the targeted vessels. Courtesy Ziyad M.
Hijazi, M.D.
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Vascular Plug
AMPLATZER Vascular Plug embolization. Courtesy
Ziyad M. Hijazi, M.D.
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