Adverse Events - Amplatzer Amulet Gebrauchsanweisung

100105566_Amulet.book Page 2 Tuesday, May 20, 2014 1:05 PM
• Remove embolized devices. Do not remove an embolized device unless the device is fully
recaptured inside a delivery sheath.
• This device should be used only by physicians who are trained in standard transcatheter
techniques. The physician should determine which patients are candidates for procedures
that use this device.
• Patients who are allergic to nickel may have an allergic reaction to this device.
• Do not use this device if the sterile package is open or damaged.
• 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.
• Use on or before the last day of the expiration month that is printed on the product packaging
label.
Precautions
• 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.
• The physician should exercise caution if implanting a device in a patient who has an
implantable cardioverter defibrillator (ICD) and leads.
• The physician should have the guidewire in the left upper pulmonary vein when making
exchanges in the left atrium.
• Ensure that the vasculature is adequate for the sheath size being selected.
• The physician should exercise caution if performing ablation at or near the implant site after
the device is implanted.
• Use standard interventional cardiovascular catheterization techniques when using
AMPLATZER™ products.
• Use in specific populations
- Pregnancy – Minimize the radiation exposure to the fetus and the mother.
- Nursing mothers – There has been no quantitative assessment for the presence of
leachables in breast milk.
MR Conditional 1
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.

Adverse Events

Potential adverse events that can occur during or after this procedure include, but are not limited
to, air embolism, allergic reaction, anesthesia reactions, arrhythmia, bleeding, cardiac arrest,
cardiac tamponade, death, device embolization, device migration, embolic event, fever, foreign
body embolization, hypertension/hypotension, infection, multi-organ failure, myocardial infarction,
perforation, pericardial effusion, renal failure/dysfunction, seizure, significant residual flow, stroke,
1. MR Conditional as defined in ASTM F 2503-05.
2