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
In non-clinical testing, the AMPLATZER™ Vascular Plug 4 produced a temperature rise of less than or equal to:
- 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.
