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The Amplatzer™ Family of Vascular Plugs

Ordering

Amplatzer™ Vascular Plug II
(AVP II)

Ordering

Sizing and Device Selection1

amplatzer vascular plug II sizing

 

A - Vascular Plug Diameter

B - Unconstrained Length

Device DimensionsVessel Size
Model/ Reorder NumberVascular Plug Diameter [A]Unconstrained Length [B]Product Description*Treatable Vessel Diameter Range†
9-AVP2-0033 mm6 mmAVP II - 3mm x 6mm2.0 mm-2.5 mm
9-AVP2-0044 mm6 mmAVP II - 4mm x 6mm2.5 mm-3.0 mm
9-AVP2-0066 mm6 mmAVP II - 6mm x 6mm4.0 mm-4.5 mm
9-AVP2-0088 mm7 mmAVP II - 8mm x 7mm5.5 mm-6.0 mm
9-AVP2-01010 mm7 mmAVP II - 10mm x 7mm6.5 mm-7.5 mm
9-AVP2-01212 mm9 mmAVP II - 12mm x 9mm8.0 mm-9.0 mm
9-AVP2-01414 mm10 mmAVP II - 14mm x 10mm9.5 mm-11.0 mm
9-AVP2-01616 mm12 mmAVP II - 16mm x 12mm10.5 mm-12.5 mm
9-AVP2-01818 mm14 mmAVP II - 18mm x 14mm12.0 mm-14.0 mm
9-AVP2-02020 mm16 mmAVP II - 20mm x 16mm13.5 mm-15.5 mm
9-AVP2-02222 mm18 mmAVP II - 22mm x 18mm14.5 mm-17.0 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 II 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)

References

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

MAT-2002814 v1.0

Important Safety Information

AMPLATZER™ Vascular Plug II

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Intended Use: The AMPLATZER™ Vascular Plug II 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:

  • 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.
  • Patients with nickel allergy can experience an allergic reaction to this device.
  • 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.
  • The physician should exercise clinical judgment in situations that involve the use of anticoagulants or antiplatelet drugs before, during, and/or after the use of this device.
  • Store in a dry place.

MRI Safety Information:

 
MRA patient with the Amplatzer™ Vascular Plug II may be safely scanned under the following conditions. Failure to follow these conditions may result in injury to the patient.
Device NameAmplatzer™ Vascular Plug II
Static Magnetic Field Strength (B0)1.5 T or 3.0 T
Maximum Field Spatial Gradient19T/m (1900 gauss/cm)
RF ExcitationCircularly Polarized (CP)
RF Transmit Coil TypeBody Coil
Operating ModeNormal Operating Mode
Maximum Whole Body SAR2.0W/kg (Normal Operating Mode)
Maximum Head SARN/A
Scan Duration2.0W/kg whole-body-averaged SAR for 15 minutes of continuous scanning
MR Image ArtifactThe presence of this implant may produce an image artifact.

 

Potential Adverse Events: Potential complications include, but are not limited to: death, migration of the device, stroke, or vessel perforation.

State of California (USA) Only:

WARNING: 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.

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MAT-2004317 v3.0

POLICIES & ADVISORIES
HEALTHCARE PROFESSIONALS
PATIENTS & CAREGIVERS
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CAUTION: These products are intended for use by or under the direction of a physician. Prior to use, reference the Instructions for Use, inside the product carton (when available) or online for more detailed information on Indications, Contraindications, Warnings, Precautions and Adverse Events.

Illustrations are artist's representations only and should not be considered as engineering drawings or photographs.

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MAT-1900882 v13.0