Device Related Adverse Event Reporting; Patient Selection And Treatment; Individualization Of Treatment; Patient Counseling Information - COOK Medical Zenith Alpha Mode D'emploi

break, occlusion, infection, stent fracture, stent corrosion, graft material
wear, dilatation, erosion, puncture, perigraft flow, barb separation
• 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)
• Local or systemic neurologic complications and subsequent attendant
problems (e.g., stroke, transient ischemic attack, paraplegia, paraparesis,
spinal cord shock, paralysis)
• Occlusion of coronary arteries
• Pulmonary embolism
• 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 problems (e.g., dehiscence, infection)

Device Related Adverse Event Reporting

Any adverse event (clinical incident) involving the Zenith Alpha Thoracic
Endovascular Graft should be reported to Cook immediately.

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 and lengths) are not certain. This approach
allows for greater intraoperative flexibility.
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 thoracic 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 anatomy (thrombus, calcification and/
or tortuosity) should be compatible with vascular access techniques and
accessories of the delivery profile of a 16 French (6 mm OD) to 20 French
(7.7 mm OD) vascular introducer sheath
• Vascular anatomy suitable for endovascular repair, including:
• radius of curvature greater than or equal to 20 mm along the entire length
of aorta intended to be treated
• Nonaneurysmal aortic segments (fixation sites) proximal and distal to the
thoracic 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 20 mm, and with localized angulations 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
thoracic 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 aneurysm or ulcer. 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 thoracic aneurysm 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, thoracic
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. Thoracic 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 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 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 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 resterilize 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; instead, return the product to Cook.
• Prior to use, verify that the 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
under sterile conditions.
• Do not use after the 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 and knowledge requirements for physicians using the
Zenith Alpha Thoracic Endovascular Graft are outlined below:

Patient Selection

• Knowledge of the natural history of thoracic aneurysms/ulcers and
comorbidities associated with thoracic aneurysm or ulcer 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; instead, return the product 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 the endovascular graft system)
• A selection of Zenith Alpha Thoracic Endovascular Graft distal ancillary
components in diameters compatible with the proximal and distal
components
• 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

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, 260/300 cm:
• Cook Lunderquist® Extra Stiff Wire Guides (LESDC)
• Cook Amplatz Ultra Stiff Wire Guides (AUS)
• .035 inch (0.89 mm) standard wire guide:
• Cook .035 inch wire guides
• Cook .035 inch Bentson Wire Guide
• Cook Nimble® Wire Guides
• Molding balloons:
• Cook Coda® Balloon Catheters
• Introducer sets:
• Cook Check-Flo® Introducer Sets
• Sizing catheter:
• Cook Aurous® Centimeter Sizing Catheters
• Angiographic radiopaque marker catheters:
• Cook Beacon® Tip Angiographic Catheters
• Cook Beacon® Tip Royal Flush Catheters, 125 cm
• Entry needles:
• Cook single-wall entry needles
• Endovascular dilators:
• 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, measure the aortic diameter using 3D
reconstructed views perpendicular to the aortic centerline of flow. The proximal
diameter of the distal component can be up to 8 mm larger than the distal
diameter of the proximal component. It is strongly recommended that you
ensure a minimum three-stent overlap between components.
For patients with a significant periaortic hematoma in the region of the
subclavian artery the hematoma should not be counted in the diameter
measurement, as there is a risk of oversizing the graft.
CTA measurements should be based on a CTA of a fully resuscitated patient.
21