Amplatzer Vascular Plug (AVP) - Ordering Information | Abbott
CARDIOVASCULAR
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The Amplatzer™ Family of Vascular Plugs

AMPLATZER™ VASCULAR PLUG (AVP)

Ordering

Sizing and Device Selection1

amplatzer vascular plug II sizing

A - Vascular Plug Diameter

B - Unconstrained Length

 

Device Dimensions Vessel Size
Model/ Reorder Number Vascular Plug Diameter [A] Unconstrained Length [B] Product Description* Treatable Vessel Diameter Range
9-PLUG-004 4 mm 7 mm AVP - 4 mm x 7 mm 2.5 mm-3.0 mm
9-PLUG-006 6 mm 7 mm AVP - 6 mm x 7 mm 4.0 mm-4.5 mm
9-PLUG-008 8 mm 7 mm AVP - 8 mm x 7 mm 5.5 mm-6.0 mm
9-PLUG-010 10 mm 7 mm AVP - 10 mm x 7 mm 6.5 mm-7.5 mm
9-PLUG-012 12 mm 8 mm AVP - 12 mm x 8 mm 8.0 mm-9.0 mm
9-PLUG-014 14 mm 8 mm AVP - 14 mm x 8 mm 9.5 mm-11.0 mm
9-PLUG-016 16 mm 8 mm AVP - 16 mm x 8 mm 10.5 mm-12.5 mm

Treatable vessel diameter range based on the devices Instructions for Use to select a plug that is oversized by approximately 30-50% at the occlusion site.
*Each Amplatzer™ Vascular Plug comes pre-loaded on a 135cm nitinol delivery wire.

Amplatzer™ Family of Vascular Plugs

  • Amplatzer Vascular Plug (AVP)
    Amplatzer™ Vascular Plug (AVP)
  • Amplatzer Vascular Plug II (AVP II)
    Amplatzer™ Vascular Plug II (AVP II)
  • Amplatzer Vascular Plug 4 (AVP 4)
    Amplatzer™ Vascular Plug 4 (AVP 4)
IMPORTANT SAFETY INFORMATION

References

  1. Amplatzer™ Vascular Plug and Vascular Plug II - Instructions for Use

MAT-2002814 v1.0

IMPORTANT SAFETY INFORMATION

rx-only-logo  AMPLATZER™ Vascular Plug

 

Intended Use: The AMPLATZER™ Vascular Plug is indicated for arterial and venous embolizations in the peripheral vasculature.

Contraindications: None known.

Warnings: The safety and effectiveness of this device for cardiac uses (for example, patent ductus arteriosus or paravalvular leak closures) and neurological uses have not been established.

Precautions:

Handling

  • Patients allergic to nickel may suffer an allergic reaction to this device.
  • This device was sterilized with ethylene oxide and is for single use only. Do not reuse or resterilize this device. Attempts to resterilize this device can cause a malfunction, insufficient sterilization, or harm to the patient.
  • Use on or before the last day of the expiration month that is printed on the product packaging label.
  • Do not use this device if the sterile package is open or damaged.
  • This device should be used only by physicians who are trained in standard endovascular techniques. The physician should determine which patients are candidates for procedures that use this device.
  • Store in a dry place.
     

MRI Safety Information:

A patient with the Amplatzer™ Vascular Plug may be safely scanned under the following conditions. Failure to follow these conditions may result in injury to the patient.
Device Name Amplatzer™ Vascular Plug
Static Magnetic Field Strength (B0) 1.5 T or 3.0 T
Maximum Field Spatial Gradient 19T/m (1900 gnauss/cm)
RF Excitation Circularly Polarized (CP)
RF Transmit Coil Type Body Coil
Operating Mode Normal Operating Mode
Maximum Whole Body SAR 2.0W/kg (Normal Operating Mode)
Maximum Head SAR N/A
Scan Duration 2.0W/kg whole-body-averaged SAR for 15 minutes of continuous scanning
MR Image Artifact The presence of this implant may produce an image artifact.

 

Potential Adverse Events: Potential complications include, but are not limited to: death, embolization of the device, hematoma at the site of entry, stroke, or vessel perforation, or embolization of the device.

State of California (USA) Only:
warningWARNING: This product can expose you to chemicals including ethylene oxide, which is known to the State of California to cause cancer and birth defects or other reproductive harm. For more information, go to www.P65Warnings.ca.gov.

MAT-2004315 v2.0

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DO YOU WISH TO CONTINUE AND EXIT CARDIOVASCULAR.ABBOTT?

CONTENTS OF THE SITE ARE NOT UNDER THE CONTROL OF ABBOTT.