How Supplied; Clinical Use Information; Physician Training; Patient Selection - COOK Medical Zenith Alpha Mode D'emploi

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 this endovascular graft has not yet
been established . All patients should be advised that endovascular
treatment requires lifelong, 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 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 AAAs . At a minimum, annual imaging and
adherence to routine postoperative follow-up requirements is required
and should be considered a lifelong 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 limb occlusion,
aneurysm enlargement or rupture . Signs of graft limb occlusion include
pain in the hip(s) or leg(s) during walking or at rest or discoloration or
coolness of the leg . Aneurysm rupture may be asymptomatic, but usually
presents as: pain; numbness; weakness in the legs; any back, chest,
abdominal or groin pain; 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
impotence .
Physicians should refer patients to the Patient Guide regarding risks
occurring during or after implantation of the device . Procedure-related risks
include cardiac, pulmonary, neurologic, bowel and bleeding complications .
Device-related risks include occlusion, endoleak, aneurysm enlargement,
fracture, potential for reintervention and open surgical conversion, rupture
and death (See Section 5, POTENTIAL ADVERSE EVENTS) . The physician
should complete the Patient ID 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 practitioners, particularly for any
additional diagnostic procedures (e .g ., MRI) .

8 HOW SUPPLIED

• STERILE - DO NOT RESTERILIZE - SINGLE USE ONLY
• The Zenith Alpha Abdominal Endovascular Graft is sterilized by ethylene
oxide gas, is preloaded into an introduction system, and is supplied in
peel-open packages .
• The device is intended for single use only . Do not re-sterilize the device .
• The product is sterile if the package is unopened and undamaged .
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 it 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 .
• The main body grafts, main body extensions and converters are loaded
in 16 Fr (6 .0 mm OD) or 17 Fr (6 .5 mm OD) Flexor introducer sheaths .
The iliac leg devices are loaded into 12 Fr (4 .7 mm OD) or 14 Fr (5 .3 mm
OD) Flexor introducer sheaths . The sheath's 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 under sterile conditions .
• Do not use after the expiration date printed on the label .
• Store in a 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 Abdominal Endovascular Graft should only
be used by physicians and teams trained in vascular interventional
techniques and in the use of this device . The recommended skill/
knowledge requirements for physicians using the Zenith Alpha
Abdominal Endovascular Graft are outlined below .

Patient selection:

• Knowledge of the natural history of abdominal aortic aneurysms (AAA)
and comorbidities associated with AAA repair
• Knowledge of radiographic image interpretation, device selection,
planning and sizing
A multidisciplinary team that has combined procedural experience
with:
• Femoral cutdown, arteriotomy and repair
• 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 it 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 three-piece modular system)
• Zenith Low Profile AAA/Zenith Alpha Abdominal Ancillary Components
• Fluoroscope with digital angiography capabilities (C-arm or fixed unit)
• Contrast media
• Syringe
• Heparinized saline solution
• Sterile gauze pads

9.4 Materials Recommended

The following products are recommended for implantation of any
component in the Zenith product line . For information on the use of these
products, refer to the individual product's Suggested Instructions for Use:
• .035 inch (0 .89 mm) extra stiff wire guide, 260 cm;
• Cook Lunderquist Extra Stiff Wire Guides (LES)
• .035 inch (0 .89 mm) standard wire guide;
• Cook .035 inch wire guides
• Cook Nimble™ Wire Guides
• Molding Balloons;
• Cook Coda® Balloon Catheter
• Introducer sets;
• Cook Check-Flo® Introducer Sets
• Cook Extra Large Check-Flo® Introducer Sets
• Cook Flexor® Balkin Up & Over® Contralateral Introducers
• Sizing catheter;
• Cook Aurous® Centimeter Sizing Catheters
• Angiographic radiopaque tip catheters;
• Cook Beacon® Tip Angiographic Catheters
• Cook Beacon® Tip Royal Flush Catheters
• Entry needles;
• Cook single wall entry needles

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 .
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