COOK Medical Zenith TX2 Gebrauchsanweisung Seite 18

3.0 Tesla Systems:
• Static magnetic field of 3.0 Tesla
• Spatial gradient field of 720 Gauss/cm
• Maximum whole-body-averaged specific absorption rate (SAR) of 2 W/kg for 15 minutes of scanning
In non-clinical testing, the Zenith TX2 TAA Endovascular Graft with Pro-Form produced a temperature
rise of less than 1.9 °C at a maximum whole-body-averaged specific absorption rate (SAR) of 3.0 W/kg
for 15 minutes of MR scanning in a 3.0 Tesla, Excite, GE Electric Healthcare MR scanner. The maximum
whole-body-averaged specific absorption rate (SAR) was 3.0 W/kg, which corresponds to a calorimetry
measured value of 2.8 W/kg.
The image artifact extends throughout the anatomical region containing the device, obscuring the view
of immediately adjacent anatomical structures within approximately 20 cm of the device, as well as the
entire device and its lumen, when scanned in nonclinical testing using the sequence: Fast spin echo in a
3.0 Tesla, Excite, GE Electric Healthcare, with G3.0-052B software, MR system with body radiofrequency
coil.
For all scanners, the image artifact dissipates as the distance from the device to the area of interest
increases. MR scans of the lower extremities may be obtained without image artifact. Image artifact
may be present in scans of the abdominal, upper extremity, and head and neck region, depending on
distance from the device to the area of interest.
Clinical information is available on six patients who received MRI scans during the course of the clini-
cal trial. There have been no reported adverse events or device problems in any of these patients as a
result of having received an MRI. Additionally, there have been approximately 3,000 patients implanted
with Zenith TAA Endovascular Grafts worldwide, in which there have been no reported adverse events
or device problems as a result of MRI.
11.5 Additional Surveillance and Treatment
(Refer to Section 4, WARNINGS AND PRECAUTIONS)
Additional surveillance and possible treatment is recommended for:
• Aneurysms with Type I endoleak
• Aneurysms with Type III endoleak
• Aneurysm enlargement, >5 mm of maximum aneurysm diameter depth (regardless of endoleak
status)
• Migration
• Inadequate seal length
Consideration for reintervention or conversion to open repair should include the attending physician's
assessment of an individual patient's co-morbidities, life expectancy, and the patient's personal choices.
Patients should be counseled that subsequent reinterventions, including catheter-based and open surgi-
cal conversion, are possible following endograft placement.
12. REFERENCES
These instructions for use are based on experience from physicians and (or) their published literature.
Refer to your local Cook sales representative for information on available literature.
14 ENGLISH I-TX2-PRO-FORM-1002-361-02