Potential Adverse Events - COOK Medical Zenith TX2 Gebrauchsanweisung

• Avoid damaging the graft or disturbing graft position after placement in the event reinstrumentation
(secondary intervention) of the graft is necessary.
• Care should be taken not to advance the sheath while the stent graft is still within it. Advancing the
sheath at this stage may cause the barbs to perforate the introducer sheath.
• To avoid entangling any catheters left in situ, rotate the delivery system during withdrawal.
4.6 Molding Balloon Use (Optional)
• Do not inflate the balloon in the aorta outside of the graft, as doing so may cause damage to the
aorta. Use the balloon in accordance with its labeling.
• Use care in inflating the balloon within the graft in the presence of calcification, as excessive infla-
tion may cause damage to the aorta.
• Confirm complete deflation of balloon prior to repositioning.
• For added hemostasis, the Captor
the insertion and subsequent withdrawal of a molding balloon.
4.7 MRI Safety and Compatibility
Non-clinical testing has demonstrated that the Zenith TX2 TAA Endovascular Graft with Pro-Form is
MR Conditional. It can be scanned safely under the following conditions:
1.5 Tesla Systems:
• Static magnetic field of 1.5 Tesla
• Spatial gradient field of 450 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 1.4 °C at a maximum whole-body-averaged specific absorption rate (SAR) of 2.8 W/kg
for 15 minutes of MR scanning in a 1.5 Tesla Magnetom, Siemens Medical Magnetom MR scanner. The
maximum whole-body-averaged specific absorption rate (SAR) was 2.8 W/kg, which corresponds to a
calorimetry measured value of 1.5 W/kg.
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 non-clinical 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 radiofre-
quency 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.

5. POTENTIAL ADVERSE EVENTS

Adverse events that may occur and/or require intervention include, but are not limited to:
• Amputation
• Anesthetic complications and subsequent attendant problems (e.g., aspiration)
• Aneurysm enlargement
• Aneurysm rupture and death
• Aortic damage, including perforation, dissection, bleeding, rupture and death
• Aorto-bronchial fistula
• Aorto-esophageal fistula
• Arterial or venous thrombosis and/or pseudoaneurysm
• Arteriovenous fistula
• Bleeding, hematoma, or coagulopathy
• Bowel complications (e.g., ileus, transient ischemia, infarction, necrosis)
• Cardiac complications and subsequent attendant problems (e.g., arrhythmia, tamponade, myocar-
dial infarction, congestive heart failure, hypotension, hypertension)
• Claudication (e.g., buttock, lower limb)
• Compartment Syndrome
• Death
• Edema
• Embolization (micro and macro) with transient or permanent ischemia or infarction
• Endoleak
• Endoprosthesis: improper component placement; incomplete component deployment; component
migration and/or separation; suture break; occlusion; infection; stent fracture; graft material wear;
dilatation; erosion; puncture; perigraft flow; barb separation and corrosion
• Femoral neuropathy
• Fever and localized inflammation
• Genitourinary complications and subsequent attendant problems (e.g., ischemia, erosion, fistula,
urinary incontinence, hematuria, infection)
• Hepatic failure
• Impotence
• Infection of the aneurysm, device or access site, including abscess formation, transient fever and pain
• Lymphatic complications and subsequent attendant problems (e.g., lymph fistula, lymphocele)
4 ENGLISH
Hemostatic Valve can be loosened or tightened to accommodate
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I-TX2-PRO-FORM-1002-361-02