THE AMPLATZER™ FAMILY OF VASCULAR PLUGS

  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.
• MR Safe

Through non-clinical testing, the AMPLATZER™ Vascular Plug has been shown to be MR safe at field strengths of 3.0 Tesla or less with a maximum whole body averaged specific absorption rate (SAR) of 3.83 W/kg at 1.5 Tesla and 5.57 W/kg at 5.0 Tesla for a 20 minute exposure to a B1 of 118 μT. The AMPLATZER™ Vascular Plug should not migrate in this MR environment. Non-clinical testing has not been performed to rule out the possibility of migration at field strengths higher than 3.0 Tesla.

In this testing, the device produced a temperature rise of 1.1°C at 1.5 Tesla and 1.6°C at 5.0 Tesla.
MR image quality may be compromised if the area of interest is in the exact same area or relatively close to the position of the device.

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: WARNING: This product and its packaging have been sterilized with ethylene oxide. The packaging may expose you to ethylene oxide, a chemical known to the State of California to cause cancer or birth defects or other reproductive harm.

  AMPLATZER™ Vascular Plug II

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.
• MR Conditional

Through non-clinical testing, AMPLATZER™ devices have been shown to be MR Conditional. A patient with an implanted AMPLATZER™ device can be scanned safely immediately after placement of the device under the following conditions:

• Static magnetic field of 3 tesla or less
• Spatial gradient magnetic field of 720 G/cm or less
• Maximum MR system-reported, whole-body-averaged specific absorption rate (SAR) of 3 W/kg for 15 minutes of scanning

During testing, the device produced a clinically non-significant temperature rise at a maximum MR system-reported, whole-body-averaged specific absorption rate (SAR) of 3 W/kg for 15 minutes of scanning in a 3-tesla MR system using a transmit/receive body coil.

MR image quality may be compromised if the area of interest is in the exact same area or relatively close to the position of the device. Therefore, optimization of MR imaging parameters to compensate for the presence of this device may be necessary.

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

  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.
• MR Conditional

Non-clinical testing has demonstrated that the AMPLATZER™ Vascular Plug 4 device is MR Conditional. It can be scanned safely under the following conditions:

• Static magnetic fields of 3.0 Tesla or less
• Spatial gradient field of 720 G/cm
• The maximum whole-body averaged specific absorption rate (SAR) shall be limited to 2.0 W/kg (normal operating mode only) for 15 minutes of scanning

• 1.6 °C at a maximum whole-body averaged specific absorption rate (SAR) of 2.1 W/Kg as assessed by calorimetry for 15 minutes of MR scanning in a
  1.5-Tesla/64MHz (Magnetom™, Siemens Medical Solutions (Malvern, PA) Software Numaris/4, Version Syngo™ MR 2002B DHHS Active-shielded, horizontal field scanner) MR system
•  1.9 °C at a maximum whole-body averaged specific absorption rate (SAR) of 2.7 W/Kg, as assessed by calorimetry for 15 minutes of MR scanning in a
  3 Tesla/128 MHz, Excite™, HDx, Software 14X.M5, General Electric Healthcare (Milwaukee, WI) MR system

MR image quality may be compromised if the area of interest is in the same area or relatively close to the position of the device. Therefore, it may be necessary to optimize MR imaging parameters for the presence of this implant.

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