Warnings; Precautions - AGA Medical AMPLATZER Mode D'emploi

3.10 Patients with thrombus at the intended site of implant.
3.11 Patients whose vasculature, through which access to the defect is gained, is inadequate to accommodate the
appropriate sheath size.
3.12 Patients with pulmonary hypertension with pulmonary vascular resistance of greater than
8 Wood units or Rp/Rs of greater than 0.4.
3.13 Patients with patent ductus arteriosus greater than 12 mm in length by angiography.
3.14 Patients with patent ductus arteriosus greater than 5.5 mm in diameter by angiography.

4. Warnings

4.1 The AMPLATZER Duct Occluder II should only be used by physicians trained in transcatheter defect-closure
techniques.
4.2 Physicians should have an on-site surgeon available in the event that surgical removal of the occluder
is required.
4.3 Do not release the device from the delivery wire if device placement is unsatisfactory or if the device position is
unstable. Recapture the device and redeploy. If still unsatisfactory, recapture the device and replace with a
new device.
4.4 Embolized devices must be removed. Embolized devices should not be withdrawn through intracardiac
structures unless they have been adequately collapsed within a catheter.
4.5 Patients allergic to nickel may suffer an allergic reaction to this device.

5. Precautions

5.1 For single use only. Do not reuse or re-sterilize.
5.2 Use before the expiration date noted on the product packaging.
5.3 Store in a dry place.
5.4 Do not use the device if the packaging sterile barrier is opened or damaged.
5.5 Patients should have an activated clotting time (ACT) of greater than 200 seconds prior to device placement.
5.6 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.
5.7 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 T 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.
1 MR Conditional as defined in ASTM F 2503-05
3