28
t/POBOFVSZTNBMJOGSBSFOBMBPSUJDTFHNFOU OFDLQSPYJNBMUPUIFBOFVSZTN
tXJUIBMFOHUIPGBUMFBTUNN
tXJUIBEJBNFUFSNFBTVSFEPVUFSXBMMUPPVUFSXBMMPGOPHSFBUFSUIBO
31 mm and no less than 19 mm,
tXJUIBOBOHMFMFTTUIBOEFHSFFTSFMBUJWFUPUIFMPOHBYJTPGUIF
aneurysm, and
tXJUIBOBOHMFMFTTUIBOEFHSFFTSFMBUJWFUPUIFBYJTPGUIFTVQSBSFOBM
aorta.
t*QTJMBUFSBMJMJBDBSUFSZEJTUBMGJYBUJPOTJUFHSFBUFSUIBONNJOMFOHUIBOE
9-21 mm in diameter (measured outer wall to outer wall).
t$POUSBMBUFSBMJMJBDBSUFSZEJTUBMGJYBUJPOTJUFHSFBUFSUIBONNJOMFOHUI
and 7-21 mm in diameter (measured outer wall to outer wall).
t'SFFEPNGSPNTJHOJGJDBOUGFNPSBMJMJBDBSUFSZPDDMVTJWFEJTFBTFUIBU
would impede flow through the endovascular graft.
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:
t3JTLTBOEEJGGFSFODFTCFUXFFOFOEPWBTDVMBSSFQBJSBOETVSHJDBMSFQBJS
t1PUFOUJBMBEWBOUBHFTPGUSBEJUJPOBMPQFOTVSHJDBMSFQBJS
t1PUFOUJBMBEWBOUBHFTPGFOEPWBTDVMBSSFQBJS
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 and compliance to 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:
t
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
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 office.
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
Reorder
Proximal Body
Proximal Body
Introduction Sheath
Introduction Sheath
Number
Diameter
Length
French Size
(I.D. / O.D.)
Length
ZFEN-P-1-24-76
24 mm
76 mm
20 Fr
6.7 mm / 7.7 mm
50 cm
ZFEN-P-1-26-76
26 mm
76 mm
20 Fr
6.7 mm / 7.7 mm
50 cm
ZFEN-P-1-28-76
28 mm
76 mm
20 Fr
6.7 mm / 7.7 mm
50 cm
ZFEN-P-1-30-76
30 mm
76 mm
20 Fr
6.7 mm / 7.7 mm
50 cm
ZFEN-P-1-32-76
32 mm
76 mm
20 Fr
6.7 mm / 7.7 mm
50 cm
ZFEN-P-1-24-91
24 mm
91 mm
20 Fr
6.7 mm / 7.7 mm
50 cm
ZFEN-P-1-26-91
26 mm
91 mm
20 Fr
6.7 mm / 7.7 mm
50 cm
ZFEN-P-1-28-91
28 mm
91 mm
20 Fr
6.7 mm / 7.7 mm
50 cm
ZFEN-P-1-30-91
30 mm
91 mm
20 Fr
6.7 mm / 7.7 mm
50 cm
ZFEN-P-1-32-91
32 mm
91 mm
20 Fr
6.7 mm / 7.7 mm
50 cm
ZFEN-P-1-24-106
24 mm
106 mm
20 Fr
6.7 mm / 7.7 mm
50 cm
ZFEN-P-1-26-106
26 mm
106 mm
20 Fr
6.7 mm / 7.7 mm
50 cm
ZFEN-P-1-28-106
28 mm
106 mm
20 Fr
6.7 mm / 7.7 mm
50 cm
ZFEN-P-1-30-106
30 mm
106 mm
20 Fr
6.7 mm / 7.7 mm
50 cm
ZFEN-P-1-32-106
32 mm
106 mm
20 Fr
6.7 mm / 7.7 mm
50 cm
ZFEN-P-1-24-121
24 mm
121 mm
20 Fr
6.7 mm / 7.7 mm
50 cm
ZFEN-P-1-26-121
26 mm
121 mm
20 Fr
6.7 mm / 7.7 mm
50 cm
ZFEN-P-1-28-121
28 mm
121 mm
20 Fr
6.7 mm / 7.7 mm
50 cm
ZFEN-P-1-30-121
30 mm
121 mm
20 Fr
6.7 mm / 7.7 mm
50 cm
ZFEN-P-1-32-121
32 mm
121 mm
20 Fr
6.7 mm / 7.7 mm
50 cm
ZFEN-P-1-34-84
34 mm
84 mm
20 Fr
6.7 mm / 7.7 mm
50 cm
ZFEN-P-1-36-84
36 mm
84 mm
22 Fr
7.3 mm / 8.5 mm
50 cm
ZFEN-P-1-34-99
34 mm
99 mm
20 Fr
6.7 mm / 7.7 mm
50 cm
ZFEN-P-1-36-99
36 mm
99 mm
22 Fr
7.3 mm / 8.5 mm
50 cm
ZFEN-P-1-34-114
34 mm
114 mm
20 Fr
6.7 mm / 7.7 mm
50 cm
ZFEN-P-1-36-114
36 mm
114 mm
22 Fr
7.3 mm / 8.5 mm
50 cm
ZFEN-P-1-34-129
34 mm
129 mm
20 Fr
6.7 mm / 7.7 mm
50 cm
ZFEN-P-1-36-129
36 mm
129 mm
22 Fr
7.3 mm / 8.5 mm
50 cm
ZFEN-P-2-24-94
24 mm
94 mm
20 Fr
6.7 mm / 7.7 mm
50 cm
ZFEN-P-2-26-94
26 mm
94 mm
20 Fr
6.7 mm / 7.7 mm
50 cm
ZFEN-P-2-28-94
28 mm
94 mm
20 Fr
6.7 mm / 7.7 mm
50 cm
ZFEN-P-2-30-94
30 mm
94 mm
20 Fr
6.7 mm / 7.7 mm
50 cm
ZFEN-P-2-32-94
32 mm
94 mm
20 Fr
6.7 mm / 7.7 mm
50 cm
ZFEN-P-2-24-109
24 mm
109 mm
20 Fr
6.7 mm / 7.7 mm
50 cm
ZFEN-P-2-26-109
26 mm
109 mm
20 Fr
6.7 mm / 7.7 mm
50 cm
ZFEN-P-2-28-109
28 mm
109 mm
20 Fr
6.7 mm / 7.7 mm
50 cm
ZFEN-P-2-30-109
30 mm
109 mm
20 Fr
6.7 mm / 7.7 mm
50 cm
ZFEN-P-2-32-109
32 mm
109 mm
20 Fr
6.7 mm / 7.7 mm
50 cm
ZFEN-P-2-24-124
24 mm
124 mm
20 Fr
6.7 mm / 7.7 mm
50 cm
ZFEN-P-2-26-124
26 mm
124 mm
20 Fr
6.7 mm / 7.7 mm
50 cm
ZFEN-P-2-28-124
28 mm
124 mm
20 Fr
6.7 mm / 7.7 mm
50 cm
ZFEN-P-2-30-124
30 mm
124 mm
20 Fr
6.7 mm / 7.7 mm
50 cm
ZFEN-P-2-32-124
32 mm
124 mm
20 Fr
6.7 mm / 7.7 mm
50 cm
ZFEN-P-2-34-107
34 mm
107 mm
20 Fr
6.7 mm / 7.7 mm
50 cm
ZFEN-P-2-36-107
36 mm
107 mm
22 Fr
7.3 mm / 8.5 mm
50 cm
ZFEN-P-2-34-122
34 mm
122 mm
20 Fr
6.7 mm / 7.7 mm
50 cm
ZFEN-P-2-36-122
36 mm
122 mm
22 Fr
7.3 mm / 8.5 mm
50 cm
ZFEN-P-2-34-137
34 mm
137 mm
20 Fr
6.7 mm / 7.7 mm
50 cm
ZFEN-P-2-36-137
36 mm
137 mm
22 Fr
7.3 mm / 8.5 mm
50 cm
