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:

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:

A 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 Name	Amplatzer™ Vascular Plug II
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, migration of the device, stroke, or vessel perforation.

State of California (USA) Only:

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 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 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: