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I-ZDEG-EU-1312-394-03
12.3 Thoracic Device Radiographs
The following views are required:
• Four films: supine-frontal (AP), cross-table lateral, 30° RPO, and 30° LPO.
• Record the table-to-film distance and use the same distance at each
subsequent examination.
• Ensure entire device is captured on each single image format lengthwise.
• The middle photocell, thoracic spine technique, or manual technique should
be used for all views to ensure adequete penetration of the mediastinum.
Ensure entire device is captured on each single image format lengthwise.
Middle photo cell should be used to fully penetrate the mediastinum and allow
visualization of the device.
If there is any concern about the device integrity (e.g., kinking, stent breaks,
relative component migration), it is recommended to use magnified views. The
attending physician should evaluate films for device integrity (entire device
length, including components) using 2-4X magnification visual aid.
12.4 MRI Information
Nonclinical testing has demonstrated that the Zenith TX2 TAA Endovascular
Graft is mr Conditional according to ASTM F2503. A patient with this
endovascular graft may be safely scanned after placement under the following
conditions.
• Static magnetic fields of 1.5 and 3.0 Tesla
• Maximum spatial magnetic gradient field of 720 Gauss/cm
• Maximum MR system reported, whole-body-averaged specific absorption
rate (SAR) of 2.0 W/kg (Normal Operating Mode) for 15 minutes of scanning
or less (i.e., per scanning sequence)
Static Magnetic Field
The static magnetic field for comparison to the above limits is the static
magnetic field that is pertinent to the patient (i.e., outside of scanner covering,
accessible to a patient or individual).
MRI-Related Heating
1.5 Tesla Temperature Rise
In nonclinical testing, the Zenith TX2 TAA Endovascular Graft produced a
temperature rise of 1.2°C (scaled to an SAR of 2.0 W/kg) during 15 minutes
of MR imaging (i.e., for one scanning sequence) performed in a MR 1.5 Tesla
System (Siemens Magnetom, Software Numaris/4).
3.0 Tesla Temperature Rise
In nonclinical testing, the Zenith TX2 TAA Endovascular Graft produced a
temperature rise of less than or equal to 1.3°C (scaled to an SAR of 2.0 W/kg)
during 15 minutes of MR imaging (i.e., for one scanning sequence) performed in
a MR 3.0 Tesla System (General Electric Excite, HDx, Software G3.0-052B).
Image Artifact
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 MR 3.0 Tesla System (General Electric Excite, HDx, Software G3.0-052B), 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 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 extremities, depending on
distance from the device to the area of interest.
For US Patients Only
Cook recommends that the patient register the MR conditions disclosed in
this IFU with the MedicAlert Foundation. The MedicAlert Foundation can be
contacted in the following manners:
Mail:
MedicAlert Foundation International
2323 Colorado Avenue
Turlock, CA 95382
Phone:
888-633-4298 (toll free)
209-668-3333 from outside the US
Fax:
209-669-2450
Web:
www.medicalert.org
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 experience from physicians and their
published literature. Refer to your local Cook Technical Representative for
information on available literature.
