The Amplatzer™ Family of Vascular Plugs

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 gauss/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: