Patient Selection And Treatment; Individualization Of Treatment; Patient Counseling Information; How Supplied - COOK Medical ZENITH ALPHA Mode D'emploi

• Pulmonary/respiratory complications and subsequent attendant problems
(e.g., pneumonia, respiratory 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, arteriovenous fistula
• Vascular spasm or vascular trauma (e.g., iliofemoral vessel dissection,
bleeding, rupture, death)
• Vessel damage
• 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 Alpha Thoracic Endovascular Graft
component diameters be selected as described in Tables 1 and 2. All lengths
and diameters of the devices necessary to complete the procedure should
be available to the physician, especially when preoperative case planning
measurements (treatment diameters/lengths) are not certain. This approach
allows for greater intraoperative flexibility to achieve optimal procedural
outcomes.
The risks and benefits should be carefully considered for each patient before
use of the Zenith Alpha Thoracic Endovascular Graft. Additional considerations
for patient selection include, but are not limited to:
• Patient's age and life expectancy
• Comorbidities (e.g., cardiac, pulmonary or renal insufficiency prior to surgery,
morbid obesity)
• Patient's suitability for open surgical repair
• The risk of aneurysm or ulcer rupture compared to the risk of treatment with
the Zenith Alpha Thoracic Endovascular Graft
• Ability to tolerate general, regional, or local anesthesia
• Ability and willingness to undergo and comply with the required follow-up
• Iliofemoral 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 16 French (6.0 mm OD) to 20 French
(7.7 mm OD) vascular introducer sheath
• Vascular morphology suitable for endovascular repair, including:
• Iliac/femoral anatomy that is suitable for access with the required
introduction systems,
• Radius of curvature greater than or equal to 20 mm along the entire
length of aorta intended to be treated.
• Non-aneurysmal aortic segments (fixation sites) proximal and distal to the
aneurysm or ulcer:
• with a length of at least 20 mm,
• with a diameter measured outer wall to outer wall of no greater than 42
mm and no less than 15 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 discussing 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 or ulcer 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 postoperative
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 ulcer, or changes in the
structure or position of the endovascular graft) should receive enhanced
follow-up. Specific follow-up guidelines are described in Section 11,
IMaGING GUIDELINES aND PoSToPERaTIVE 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 treatment
of thoracic aortic aneurysms or ulcers. At a minimum, annual imaging and
adherence to routine postoperative 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 or ulcer 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
or ulcer enlargement or rupture. Signs of graft occlusion include, but may
not be limited to, pulse-less legs, ischemia of intestines, and cold extremities.
Aneurysm or ulcer 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 risk 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
impotence.
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 any time he/she visits additional health practitioners, particularly for any
additional diagnostic procedures (e.g., MRI).

8 HOW SUPPLIED

• The Zenith Alpha Thoracic Endovascular Graft is supplied sterilized by
ethylene oxide gas, is preloaded onto an introduction system, and is
supplied in peel-open packages.
• The device is intended for single use only. Do not attempt to re-sterilize the
device.
• Inspect the device and packaging to verify that no damage has occurred as
a result of shipping. Do not use this device if damage has occurred or if the
sterilization barrier has been damaged or broken. If damage has occurred,
do not use the product and return to COOK.
I-ALPHA-TAA-1306-436-01
• Prior to use, verify correct devices (quantity and size) have been supplied for
the patient by matching the device to the order prescribed by the physician
for that particular patient.
• The device is loaded into a 16 French, 18 French or 20 French Flexor
Introducer Sheath. Its surface is treated with a hydrophilic coating that,
when hydrated, enhances trackability. To activate the hydrophilic coating,
the surface must be wiped with a sterile gauze pad soaked in saline solution.
• Do not use after the "use by" (expiration) date printed on the label.
• Store in a dark, cool, dry place.

9 CLINICAL USE INFORMATION

9.1 Physician Training

CAUTION: Always have a qualified surgery team available during
implantation or reintervention procedures in the event that conversion to
open surgical repair is necessary.
CAUTION: The Zenith Alpha Thoracic Endovascular Graft should only be
used by physicians and teams trained in vascular interventional techniques
(endovascular and surgical) and in the use of this device. The recommended
skill/knowledge requirements for physicians using the Zenith Alpha Thoracic
Endovascular Graft are outlined below:

Patient selection

• Knowledge of the natural history of thoracic aortic aneurysms (TAA) or ulcers
and comorbidities associated with TAA repair.
• Knowledge of radiographic image interpretation, patient selection, device
selection, planning and sizing.
a multidisciplinary team that has combined procedural experience with:
• Femoral and brachial cutdown, arteriotomy, and repair or conduit technique
• Percutaneous access and closure techniques
• Nonselective and selective wire guide and catheter techniques
• Fluoroscopic and angiographic image interpretation
• Embolization
• Angioplasty
• Endovascular stent placement
• Snare techniques
• Appropriate use of radiographic contrast material
• Techniques to minimize radiation exposure
• Expertise in necessary patient follow-up modalities

9.2 Inspection Prior to Use

Inspect the device and packaging to verify that no damage has occurred as
a result of shipping. Do not use this device if damage has occurred or if the
sterilization barrier has been damaged or broken. If damage has occurred, do
not use the product and return to COOK.
• Prior to use, verify correct devices (quantity and size) have been supplied for
the patient by matching the device to the order prescribed by the physician
for that particular patient.

9.3 Materials Required

(Not included in two-piece modular system)
• A selection of Zenith Alpha Thoracic Endovascular Graft distal ancillary
components in diameters compatible with the two-piece system are
available.
• Fluoroscope with digital angiography capabilities (C-arm or fixed unit)
• Contrast media
• Power injector
• Syringe
• Heparinized saline solution
• Sterile gauze pads

9.4 Materials Recommended

(Not included in the two-piece modular system or ancillary components)
The following products are recommended for implantation of any component
in the Zenith product line. For information on these products, refer to the
individual products suggested Instruction for Use.
• .035 inch (0.89 mm) extra stiff wire guide, 260/300 cm; for example:
• Cook Lunderquist Extra Stiff Wire Guides (LESDC)
• Cook Amplatz Ultra Stiff Wire Guides (AUS)
• .035 inch (0.89 mm) standard wire guide; for example:
• Cook .035 inch Wire Guides
• Cook .035 inch Bentson Wire Guide
• Cook Nimble® Wire Guides
• Molding Balloons; for example
• Cook Coda® Balloon Catheters
• Introducer sets; for example:
• Cook Check-Flo® Introducer Sets
• Sizing catheter; for example:
• Cook Aurous® Centimeter Sizing Catheters
• Angiographic radiopaque marker catheters; for example:
• Cook Beacon® Tip Angiographic Catheters
• Cook Beacon® Tip Royal Flush Catheters, 125 cm
• Entry needles; for example:
• Cook single wall entry needles
• Endovascular Dilators; for example:
• Cook Endovascular Dilator Sets

9.5 Device Diameter Sizing Guidelines

The choice of diameter should be determined from the outer wall to outer
wall vessel diameter and not the lumen diameter. Undersizing or oversizing
may result in incomplete sealing or compromised flow. In order to ensure
accurate diameter measurements for the purpose of graft sizing, particularly
when in curved segments of the aorta, measuring the aortic diameter using
3D reconstructed views perpendicular to the aortic centerline of flow may be
important. The proximal diameter of the distal component can be up to 8 mm
larger in diameter than the distal diameter of the proximal component. Strict
adherence to a minimum overlap of 3 stents between components is strongly
reccommended.
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