Amplatzer Vascular Plug 4 (AVP 4) - Ordering Information | Abbott
CARDIOVASCULAR
hamburger
The Amplatzer™ Family of Vascular Plugs

AMPLATZER™ VASCULAR PLUG 4
(AVP 4)

Ordering

Sizing and Device Selection1

amplatzer vascular plug 4 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-AVP038-004 4 mm 10.0 mm AVP 4 - 4mm x 10.0mm 2.5-3.0 mm
9-AVP038-005 5 mm 10.5 mm AVP 4 - 5mm x 10.5mm 3.5-4.0 mm
9-AVP038-006 6 mm 11.0 mm AVP 4 - 6mm x 11.0mm 4.0-4.5 mm
9-AVP038-007 7 mm 12.5 mm AVP 4 - 7mm x 12.5mm 4.5-5.5 mm
9-AVP038-008 8 mm 13.5 mm AVP 4 - 8mm x 13.5mm 5.5-6.0 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 4 comes pre-loaded and packaged on an 0.038" x 155cm-long PTFE-coated 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 4 – Instructions for Use

MAT-2002814 v1.0

IMPORTANT SAFETY INFORMATION

rx-only-logo  AMPLATZER™ Vascular Plug 4

 

Indications And Usage: The AMPLATZER™ Vascular Plug 4 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 (eg, cardiac septal occlusion, patent ductus arteriosus, paravalvular leak closures) and neurologic uses have not been established.
  • Do not use this device if the sterile package is open or damaged.
  • Use on or before the last day of the expiration month that is printed on the product packaging label.
  • The 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.
  • Do not use a power injection syringe to inject contrast solution through this device.
  • Physicians must be prepared to deal with urgent situations, such as device embolization, which require removal of the device. This includes the availability of an on-site surgeon.


Precautions:

  • The AMPLATZER™ Vascular Plug 4 device consists of a nickel-titanium alloy, which is generally considered safe. However, in vitro testing has demonstrated that nickel is released from this device for a minimum of 60 days. Patients who are allergic to nickel may have an allergic reaction to this device, especially those with a history of metal allergies. Certain allergic reactions can be serious; patients should be instructed to notify their physicians immediately if they suspect they are experiencing an allergic reaction such as difficulty breathing or inflammation of the face or throat. Some patients may also develop an allergy to nickel if this device is implanted.
  • The physician should exercise clinical judgment in situations that involve the use of anticoagulants or antiplatelet drugs before, during, and/or after use of the device.
  •  Store in a dry place.
  • 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.
  • Use in specific populations
    • Pregnancy - care should be taken to minimize the radiation exposure to the
      fetus and the mother.
    • Nursing mothers - there has been no quantitative assessment of the presence
      of leachables in breast milk.
       

MRI Safety Information:

A patient with the Amplatzer™ Vascular Plug 4 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 4
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 adverse events that may occur during or after a procedure placing this device include, but are not limited to:

  • Air embolus
  • Allergic reaction/toxic effects
  • Bleeding
  • Death
  • Device migration
  • Fever
  • Foreign material embolic event
  • Hemolysis
  • Infection
  • Occlusion of unintended vessel
  • Peripheral embolism
  • Recanalization
  • Residual flow
  • Stroke/TIA
  • Surgical intervention
  • Vascular access site complication
  • Vessel trauma/perforation

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-2004318 v2.0

DO YOU WISH TO CONTINUE AND EXIT CARDIOVASCULAR.ABBOTT?

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

False
accessibility
© 2021 Abbott. All Rights Reserved. Please read the Legal Notice for further details.

Unless otherwise specified, all product and service names appearing in this Internet site are trademarks owned by or licensed to Abbott, its subsidiaries or affiliates. No use of any Abbott trademark, trade name, or trade dress in this site may be made without the prior written authorization of Abbott, except to identify the product or services of the company.

accessibility

DO YOU WISH TO CONTINUE AND EXIT CARDIOVASCULAR.ABBOTT?

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