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implanted to address paravalvular leakage, in combination with the referenced valves,
can be safely scanned in an MR system under the following conditions:
- Static magnetic field of 1.5 Tesla (1.5T) or 3.0-Tesla (3.0T)
- Maximum spatial gradient field of 19 T/m (1900 G/cm)
- Maximum MR system reported, whole-body averaged specific absorption rate
(SAR) of 2.0 W/kg (normal operating mode)
Under the scan conditions defined above, the device is expected to produce a
maximum temperature rise of less than or equal to 3°C after 15 minutes of continuous
scanning.
In non-clinical testing, the image artifact caused by the device extends radially up to
1.8 cm and 3.6 cm (respectively) from the device when imaged with a gradient echo
pulse sequence in a 1.5T MR system and a spin echo pulse sequence in a 3.0T MR
system.
Potential Adverse Events
Potential adverse events associated with the device include, but are not limited to, vascular
access-site and access-related complications, including pseudoaneurysm, hematoma and
need for transfusion; bleeding; pericardial effusion, tamponade, hemothorax, pulmonary
edema; air embolism, pneumothorax; interference with the function of the valve, coronary
obstruction, impaired hemodynamics; residual, recurrent (or both) regurgitation due to
procedural failure; mechanical leaflet escape, fracture, or blockage causing acute massive
regurgitation; conversion to emergency surgery or need for later reoperation; endocarditis of
the device or the valve caused by device infection; device or valve thrombosis, device
embolization, migration or dislodgement, valve dehiscence or prolapse, complications due to
transseptal crossing such as longer procedure times, new or worsening hemolytic anemia;
acute kidney injury; ventricular tachycardia, ventricular fibrillation, arrhythmia, atrioventricular
block; coronary injury, cardiac perforation, acute myocardial infarction, heart failure;
ventricular perforation, aortic dissection, tamponade; thrombus, stroke, including transient
ischemic attack, and death resulting from an adverse event.
Directions for Use
Materials recommended for use with the Amplatzer™ Valvular Plug III:
• Delivery catheter that is appropriate for the device size as indicated in Table 1 in
Appendix A: Supplemental Information. (If preferred, a delivery sheath may be used to
deliver the device; make sure that the inner diameter of the sheath can accommodate
the device as specified in Table 1.)
• Y-connector kit
• 20-cc syringe with sterile saline
Procedure
1. After having diagnosed the presence of a paravalvular leak and having determined
its location, shape, and size using TEE, TTE, CT, or other appropriate imaging
modalities, select a device using the sizing chart (Table 2) in Appendix A:
Supplemental Information. Note that the device sizes recommended in the sizing
chart are greater than 20% larger in area than the corresponding area to be
occluded.
2. Make sure that the occlusion site is long enough to accommodate the implanted
device without unintentionally interfering with the valve function or obstructing
coronary arteries. Table 1 in Appendix A: Supplemental Information lists the
dimensions of the device when it is uncompressed. Note that the device will
lengthen when implanted in a valve, and the increase in length will vary depending
on the paravalvular leak, adjacent tissue, and sutures from the annulus.
3. Select a delivery catheter with the dimensions listed in Table 1 in Appendix A:
Supplemental Information. French sizes are given as a reference. Refer to the
delivery catheter labeling to find the inner diameter (ID) and ensure that it is
sufficient to accommodate the device.
3
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