Adverse Events; Directions For Use - Amplatzer Duct Occluder II Gebrauchsanweisung

• Prepare for situations that require the removal of this device. Preparation includes
access to an on-site surgeon.
• Remove embolized devices. Do not remove an embolized occluder through intracardiac
structures unless the occluder is fully recaptured inside a catheter.
• Remove the occluder if it extends more than halfway across the left pulmonary artery.
• Accurate measurements of the ductus are crucial for correct occluder size selection.
• Do not release the occluder from the delivery wire if a retention disc extends into either
vessel or if the position of the occluder is not stable.
Precautions
• This device should be used only by physicians who are trained in standard
transcatheter techniques.
• Determine which patients are candidates for procedures that use this device.
• Use clinical judgment in situations that use anticoagulants or antiplatelet medication
before, during, and after the use of this device.
• Use in specific populations
- Pregnancy – Minimize 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
Through nonclinical 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 nonsignificant temperature rise at a
maximum MR system-reported, whole-body-averaged 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 embolus, allergic reaction, endocarditis, bleeding, death, device embolization,
device migration, embolic event, fever, foreign material embolic event, hemolysis, infection,
pressure gradient, pulmonary hypertension, residual shunt, stroke, thromboembolic event,
thrombus, transient ischemic attack, tissue trauma or damage, valvular insufficiency,
vascular access site complications, and vessel trauma or damage.

Directions for Use

Materials recommended for use with this device
• AMPLATZER TorqVue
• 0.035-inch (0.89-mm) guidewire
Procedure
1. Prepare the patient for a standard transcatheter procedure. Give the patient oral
antiplatelet medication. Continue anticoagulation medication during and after the
procedure.
2. Do a right-heart catheterization.
3. Take hemodynamic measurements.
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LP Catheter (9-TVLPC4F90/080)
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