Additional Surveillance And Treatment; References - COOK Medical Zenith TX2 Instrucciones De Uso

3.0 Tesla Systems:
• Static magnetic field of 3.0 Tesla
• Maximum whole body averaged specific ab-
sorption rate (SAR) of 2 W/kg for 15 minutes
of scanning (i.e., per scanning sequence)
In non-clinical testing, the Zenith TX2 TAA Endo-
vascular Graft with the Z-Trak Plus Introduction
System produced a temperature rise of less than
or equal to 1.9°C at a maximum whole body av-
eraged specific absorption rate (SAR) of 3.0 W/kg,
for 15 minutes of MR scanning in a 3.0 Tesla Ex-
cite, GE Electric Healthcare, G3.0-052B Software,
MR Scanner. The maximum whole body aver-
aged specific absorption rate (SAR) was 3.0 W/
kg, which corresponds to a calorimetry measured
value of 2.8 W/kg.
Image Artifact
The image artifact extends throughout the ana-
tomical 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 se-
quence: 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 inter-
est increases. MR scans of the head and neck
and lower extremities may be obtained without
image artifact. Image artifact may be present
in scans of the abdominal region and upper ex-
tremities, depending on distance from the device
to the area of interest.
Clinical information is available for seventeen
patients who received MRI scans after stent-graft
implantation. There have been no reported ad-
verse events or device problems in any of these
patients as a result of having received an MRI.
12.5 Additional Surveillance and Treatment
Additional surveillance and possible treatment is
recommended for:
• 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 surgical conversion, are
possible following endograft placement.
13 REFERENCES
These Instructions for Use are based on experi-
ence from physicians and their published litera-
ture. Refer to your local Cook Technical Repre-
sentative for information on available literature.
I-ZDEG-EU-1105-394-02 ENGLISH 13