Patient Counseling Information - COOK Medical Zenith TX2 Gebrauchsanweisung

• Local or systemic neurologic complications and subsequent attendant problems (e.g., stroke, tran-
sient ischemic attack, paraplegia, paraparesis/spinal cord shock, paralysis)
• Occlusion of device or native vessel
• Pulmonary Embolism
• Pulmonary/respiratory complications and subsequent attendant problems (e.g., pneumonia, respira-
tory failure, prolonged intubation)
• Renal complications and subsequent attendant problems (e.g., artery occlusion, contrast toxicity,
insufficiency, failure)
• Surgical conversion to open repair
• Vascular access site complications, including infection, pain, hematoma, pseudoaneurysm, arterio-
venous fistula
• Vascular spasm or vascular trauma (e.g., ilio-femoral vessel dissection, bleeding, rupture, death)
• Wound complications and subsequent attendant problems (e.g., dehiscence, infection)
6. PATIENT SELECTION AND TREATMENT
(See Section 4, WARNINGS AND PRECAUTIONS)
6.1 Individualization of Treatment
Cook recommends that the Zenith TX2 TAA Endovascular Graft with Pro-Form component diameters
be selected as described in Tables 10.1 and 10.2. All lengths and diameters of the devices necessary to
complete the procedure should be available to the physician, especially when pre-operative case plan-
ning measurements (treatment diameters/lengths) are not certain. This approach allows for greater
intra-operative flexibility to achieve optimal procedural outcomes. The risks and benefits should be
carefully considered for each patient before use of the Zenith TX2 TAA Endovascular Graft with Pro-
Form. Additional considerations for patient selection include but are not limited to:
• Patient's age and life expectancy
• Co-morbidities (e.g., cardiac, pulmonary or renal insufficiency prior to surgery, morbid obesity)
• Patient's suitability for open surgical repair
• The risk of aneurysm rupture compared to the risk of treatment with the Zenith TX2 TAA Endovascu-
lar Graft with Pro-Form
• Ability to tolerate general, regional, or local anesthesia
• Ability and willingness to undergo and comply with the required follow-up
• Ilio-femoral access vessel size and morphology (thrombus, calcification and/or tortuosity) should be
compatible with vascular access techniques and accessories of the delivery profile of a 20 French to
22 French vascular introducer sheath
• Vascular morphology suitable for endovascular repair, including:
• Adequate iliac/femoral access compatible with the required introduction systems,
• Radius of curvature greater than 35 mm along the entire length of aorta intended to be treated.
• Non-aneurysmal aortic segments (fixation sites) proximal and distal to the aneurysm:
• with a length of at least 20 mm,
• with a diameter measured outer wall to outer wall of no greater than 38 mm and no less than
20 mm, and
• with an angle less than 45 degrees.
The final treatment decision is at the discretion of the physician and patient.

7. PATIENT COUNSELING INFORMATION

The physician and patient (and/or family members) should review the risks and benefits when discuss-
ing this endovascular device and procedure including:
• Risks and differences between endovascular repair and open surgical repair
• Potential advantages of traditional open surgical repair
• Potential advantages of endovascular repair
• The possibility that subsequent interventional or open surgical repair of the aneurysm may be
required after initial endovascular repair
In addition to the risks and benefits of an endovascular repair, the physician should assess the patient's
commitment to and compliance with post-operative follow-up as necessary to ensure continuing safe
and effective results. Listed below are additional topics to discuss with the patient as to expectations
after an endovascular repair:
• The long-term performance of endovascular grafts has not yet been established. All patients
should be advised that endovascular treatment requires life-long, regular follow-up to assess their
health and the performance of their endovascular graft. Patients with specific clinical findings
(e.g., endoleaks, enlarging aneurysms, or changes in the structure or position of the endovascular
graft) should receive enhanced follow-up. Specific follow-up guidelines are described in Section 12,
IMAGING GUIDELINES AND POST-OPERATIVE FOLLOW-UP.
• Patients should be counseled on the importance of adhering to the follow-up schedule, both during
the first year and at yearly intervals thereafter. Patients should be told that regular and consistent
follow-up is a critical part of ensuring the ongoing safety and effectiveness of endovascular treat-
ment of thoracic aortic aneurysms. At a minimum, annual imaging and adherence to routine post-
operative follow-up requirements is required and should be considered a life-long commitment to
the patient's health and well-being.
• The patient should be told that successful aneurysm repair does not arrest the disease process. It is
still possible to have associated degeneration of vessels.
• Physicians must advise every patient that it is important to seek prompt medical attention if he/
she experiences signs of graft occlusion, aneurysm enlargement or rupture. Symptoms of graft
occlusion include, but may not be limited to, pulse-less legs, pain, ischemia of intestines, and cold
extremities. Aneurysm rupture may be asymptomatic, but usually presents as back or chest pain,
persistent cough, dizziness, fainting, rapid heartbeat, or sudden weakness.
• Due to the imaging required for successful placement and follow-up of endovascular devices, the
risks of radiation exposure to developing tissue should be discussed with women who are or suspect
they are pregnant. Men who undergo endovascular or open surgical repair may experience impo-
tence.
The physician should complete the Patient Card and give it to the patient so that he/she can carry it with
him/her at all times. The patient should refer to the card anytime he/she visits additional health prac-
titioners, particularly for any additional diagnostic procedures (e.g., MRI). For additional information,
please refer to the Zenith TX2 TAA Endovascular Graft with Pro-Form Patient Guide.
I-TX2-PRO-FORM-1002-361-02 ENGLISH 5