Patient Counseling Information; How Supplied; Proximal Body Graft - COOK Medical Zenith Fenestrated AAA Instructions For Use Manual

31 mm and no less than 19 mm,
aneurysm, and
aorta.
9-21 mm in diameter (measured outer wall to outer wall).
and 7-21 mm in diameter (measured outer wall to outer wall).
would impede flow through the endovascular graft.
The nal 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 bene ts when discussing this endovascular device and procedure
including:
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 bene ts of an endovascular repair, the physician
should assess the patient's commitment and compliance to post-operative
follow-up as necessary to ensure continuing safe and e ective results.
Listed below are additional topics to discuss with the patient as to
expectations after an endovascular repair:
The long-term performance and safety of endovascular grafts has
not yet been established. As a result, life-long, regular follow-up must
be undertaken in all patients to assess the ongoing performance of the
Reorder Proximal Body
Number Diameter
ZFEN-P-1-24-76 24 mm
ZFEN-P-1-26-76 26 mm
ZFEN-P-1-28-76 28 mm
ZFEN-P-1-30-76 30 mm
ZFEN-P-1-32-76 32 mm
ZFEN-P-1-24-91 24 mm
ZFEN-P-1-26-91 26 mm
ZFEN-P-1-28-91 28 mm
ZFEN-P-1-30-91 30 mm
ZFEN-P-1-32-91 32 mm
ZFEN-P-1-24-106 24 mm
ZFEN-P-1-26-106 26 mm
ZFEN-P-1-28-106 28 mm
ZFEN-P-1-30-106 30 mm
ZFEN-P-1-32-106 32 mm
ZFEN-P-1-24-121 24 mm
ZFEN-P-1-26-121 26 mm
ZFEN-P-1-28-121 28 mm
ZFEN-P-1-30-121 30 mm
ZFEN-P-1-32-121 32 mm
ZFEN-P-1-34-84 34 mm
ZFEN-P-1-36-84 36 mm
ZFEN-P-1-34-99 34 mm
ZFEN-P-1-36-99 36 mm
ZFEN-P-1-34-114 34 mm
ZFEN-P-1-36-114 36 mm
ZFEN-P-1-34-129 34 mm
ZFEN-P-1-36-129 36 mm
ZFEN-P-2-24-94 24 mm
ZFEN-P-2-26-94 26 mm
ZFEN-P-2-28-94 28 mm
ZFEN-P-2-30-94 30 mm
ZFEN-P-2-32-94 32 mm
ZFEN-P-2-24-109 24 mm
ZFEN-P-2-26-109 26 mm
ZFEN-P-2-28-109 28 mm
ZFEN-P-2-30-109 30 mm
ZFEN-P-2-32-109 32 mm
ZFEN-P-2-24-124 24 mm
ZFEN-P-2-26-124 26 mm
ZFEN-P-2-28-124 28 mm
ZFEN-P-2-30-124 30 mm
ZFEN-P-2-32-124 32 mm
ZFEN-P-2-34-107 34 mm
ZFEN-P-2-36-107 36 mm
ZFEN-P-2-34-122 34 mm
ZFEN-P-2-36-122 36 mm
ZFEN-P-2-34-137 34 mm
ZFEN-P-2-36-137 36 mm
Zenith Fenestrated AAA 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 Post-Operative Follow-Up.

8 HOW SUPPLIED

The Zenith Fenestrated AAA Endovascular Graft is supplied sterile (100%
ethylene oxide) and pre-loaded in peel-open packages.
This device is intended for single patient use only. Do not reuse, reprocess
or resterilize any part of this device. Reuse, reprocessing, or resterilization
may compromise the structural integrity of the device and/or lead to device
failure, which in turn, may result in patient injury, illness or death. Reuse,
reprocessing, or resterilization may also create a risk of contamination of
the device and/or cause patient infection or cross-infection, including, but
not limited to, the transmission of infectious disease(s) from one patient to
another. Contamination of the device may lead to injury, illness or death
of the patient. 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 sterilisation barrier has been damaged or broken.
If damage has occurred, do not use the product and return to your Cook
representative or your nearest Cook o ce.
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. Do not use after the expiration date
printed on the label. Store in a cool dry place.
The proximal body and distal bifurcated body grafts are loaded into either
a 20 French or 22 French Flexor introducer sheath. The sheath's surface
is treated with a hydrophilic coating that, when activated, enhances
trackability. To activate the hydrophilic coating, the surface must be wiped
with a 4x4 gauze pad soaked in saline solution.
The Zenith Fenestrated AAA Endovascular Graft and delivery systems are
available in the lengths and diameters detailed on pages 28 to 29.

8.1 Proximal Body Graft

Proximal Body Introduction Sheath
Length French Size
76 mm 20 Fr
76 mm 20 Fr
76 mm 20 Fr
76 mm 20 Fr
76 mm 20 Fr
91 mm 20 Fr
91 mm 20 Fr
91 mm 20 Fr
91 mm 20 Fr
91 mm 20 Fr
106 mm 20 Fr
106 mm 20 Fr
106 mm 20 Fr
106 mm 20 Fr
106 mm 20 Fr
121 mm 20 Fr
121 mm 20 Fr
121 mm 20 Fr
121 mm 20 Fr
121 mm 20 Fr
84 mm 20 Fr
84 mm 22 Fr
99 mm 20 Fr
99 mm 22 Fr
114 mm 20 Fr
114 mm 22 Fr
129 mm 20 Fr
129 mm 22 Fr
94 mm 20 Fr
94 mm 20 Fr
94 mm 20 Fr
94 mm 20 Fr
94 mm 20 Fr
109 mm 20 Fr
109 mm 20 Fr
109 mm 20 Fr
109 mm 20 Fr
109 mm 20 Fr
124 mm 20 Fr
124 mm 20 Fr
124 mm 20 Fr
124 mm 20 Fr
124 mm 20 Fr
107 mm 20 Fr
107 mm 22 Fr
122 mm 20 Fr
122 mm 22 Fr
137 mm 20 Fr
137 mm 22 Fr
28
Introduction Sheath
(I.D. / O.D.) Length
6.7 mm / 7.7 mm 50 cm
6.7 mm / 7.7 mm 50 cm
6.7 mm / 7.7 mm 50 cm
6.7 mm / 7.7 mm 50 cm
6.7 mm / 7.7 mm 50 cm
6.7 mm / 7.7 mm 50 cm
6.7 mm / 7.7 mm 50 cm
6.7 mm / 7.7 mm 50 cm
6.7 mm / 7.7 mm 50 cm
6.7 mm / 7.7 mm 50 cm
6.7 mm / 7.7 mm 50 cm
6.7 mm / 7.7 mm 50 cm
6.7 mm / 7.7 mm 50 cm
6.7 mm / 7.7 mm 50 cm
6.7 mm / 7.7 mm 50 cm
6.7 mm / 7.7 mm 50 cm
6.7 mm / 7.7 mm 50 cm
6.7 mm / 7.7 mm 50 cm
6.7 mm / 7.7 mm 50 cm
6.7 mm / 7.7 mm 50 cm
6.7 mm / 7.7 mm 50 cm
7.3 mm / 8.5 mm 50 cm
6.7 mm / 7.7 mm 50 cm
7.3 mm / 8.5 mm 50 cm
6.7 mm / 7.7 mm 50 cm
7.3 mm / 8.5 mm 50 cm
6.7 mm / 7.7 mm 50 cm
7.3 mm / 8.5 mm 50 cm
6.7 mm / 7.7 mm 50 cm
6.7 mm / 7.7 mm 50 cm
6.7 mm / 7.7 mm 50 cm
6.7 mm / 7.7 mm 50 cm
6.7 mm / 7.7 mm 50 cm
6.7 mm / 7.7 mm 50 cm
6.7 mm / 7.7 mm 50 cm
6.7 mm / 7.7 mm 50 cm
6.7 mm / 7.7 mm 50 cm
6.7 mm / 7.7 mm 50 cm
6.7 mm / 7.7 mm 50 cm
6.7 mm / 7.7 mm 50 cm
6.7 mm / 7.7 mm 50 cm
6.7 mm / 7.7 mm 50 cm
6.7 mm / 7.7 mm 50 cm
6.7 mm / 7.7 mm 50 cm
7.3 mm / 8.5 mm 50 cm
6.7 mm / 7.7 mm 50 cm
7.3 mm / 8.5 mm 50 cm
6.7 mm / 7.7 mm 50 cm
7.3 mm / 8.5 mm 50 cm