30
9 CLINICAL USE INFORMATION
9.1 Physician Training
CAUTION: Always have a vascular surgery team available during
implantation or reintervention procedures in the event that conversion
to open surgical repair is necessary.
CAUTION: The Zenith Fenestrated AAA Endovascular Graft with the
H&L-B One-Shot Introduction System MUST 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 Fenestrated AAA Endovascular Graft with
the H&L-B One-Shot Introduction System are outlined below:
Patient Selection:
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and co-morbidities associated with AAA repair.
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sizing.
A multi-disciplinary team that has combined procedural experience
with:
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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 sterilisation barrier has been damaged or broken. If damage has
occurred, do not use the product and return to the nearest Cook office
or Representative. 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 3-piece modular system)
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9.4 Materials Recommended
(Not included in 3-piece modular system)
The following products are recommended:
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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.
9.5.1 Proximal Body Graft Diameter Sizing
Intended Aortic
Main Body
Introduction Sheath
Vessel Diameter
Diameter
French Size
(I.D. / O.D.)
19 mm
24 mm
20 Fr
6.7 mm / 7.7 mm
20 mm
24 mm
20 Fr
6.7 mm / 7.7 mm
21 mm
24 mm
20 Fr
6.7 mm / 7.7 mm
21 mm
26 mm
20 Fr
6.7 mm / 7.7 mm
22 mm
26 mm
20 Fr
6.7 mm / 7.7 mm
23 mm
28 mm
20 Fr
6.7 mm / 7.7 mm
24 mm
28 mm
20 Fr
6.7 mm / 7.7 mm
24 mm
30 mm
20 Fr
6.7 mm / 7.7 mm
25 mm
30 mm
20 Fr
6.7 mm / 7.7 mm
26 mm
30 mm
20 Fr
6.7 mm / 7.7 mm
26 mm
32 mm
20 Fr
6.7 mm / 7.7 mm
27 mm
32 mm
20 Fr
6.7 mm / 7.7 mm
28 mm
32 mm
20 Fr
6.7 mm / 7.7 mm
28 mm
34 mm
20 Fr
6.7 mm / 7.7 mm
29 mm
34 mm
20 Fr
6.7 mm / 7.7 mm
29 mm
36 mm
22 Fr
7.3 mm / 8.5 mm
30 mm
36 mm
22 Fr
7.3 mm / 8.5 mm
31 mm
36 mm
22 Fr
7.3 mm / 8.5 mm
9.5.2 Distal Ipsilateral Graft Diameter Sizing
Intended Iliac
Ipsilateral
Introduction Sheath
Vessel Diameter
Fenestrated Leg
French Size
(I.D. / O.D.)
9 mm
12 mm
20 Fr
6.7 mm / 7.7 mm
10 mm
12 mm
20 Fr
6.7 mm / 7.7 mm
11 mm
12 mm
20 Fr
6.7 mm / 7.7 mm
12 mm
16 mm
20 Fr
6.7 mm / 7.7 mm
13 mm
16 mm
20 Fr
6.7 mm / 7.7 mm
14 mm
16 mm
20 Fr
6.7 mm / 7.7 mm
15 mm
16 mm
20 Fr
6.7 mm / 7.7 mm
15 mm
20 mm
20 Fr
6.7 mm / 7.7 mm
16 mm
20 mm
20 Fr
6.7 mm / 7.7 mm
17 mm
20 mm
20 Fr
6.7 mm / 7.7 mm
18 mm
20 mm
20 Fr
6.7 mm / 7.7 mm
18 mm
24 mm
20 Fr
6.7 mm / 7.7 mm
19 mm
24 mm
20 Fr
6.7 mm / 7.7 mm
20 mm
24 mm
20 Fr
6.7 mm / 7.7 mm
21 mm
24 mm
20 Fr
6.7 mm / 7.7 mm
9.5.3 Iliac Leg Graft Diameter Sizing
Intended Iliac
Iliac Leg
Introduction Sheath
Vessel Diameter
Diameter
French Size
(I.D. / O.D.)
7 mm
8 mm
14 Fr
4.7 mm / 5.3 mm
8 mm
10 mm
14 Fr
4.7 mm / 5.3 mm
9 mm
10 mm
14 Fr
4.7 mm / 5.3 mm
9 mm
12 mm
14 Fr
4.7 mm / 5.3 mm
10 mm
12 mm
14 Fr
4.7 mm / 5.3 mm
11 mm
12 mm
14 Fr
4.7 mm / 5.3 mm
12 mm
14 mm
14 Fr
4.7 mm / 5.3 mm
13 mm
14 mm
14 Fr
4.7 mm / 5.3 mm
13 mm
16 mm
14 Fr
4.7 mm / 5.3 mm
14 mm
16 mm
14 Fr
4.7 mm / 5.3 mm
15 mm
16 mm
14 Fr
4.7 mm / 5.3 mm
15 mm
18 mm
16 Fr
5.3 mm / 6.0 mm
16 mm
18 mm
16 Fr
5.3 mm / 6.0 mm
16 mm
20 mm
16 Fr
5.3 mm / 6.0 mm
17 mm
18 mm
16 Fr
5.3 mm / 6.0 mm
17 mm
20 mm
16 Fr
5.3 mm / 6.0 mm
18 mm
20 mm
16 Fr
5.3 mm / 6.0 mm
18 mm
22 mm
16 Fr
5.3 mm / 6.0 mm
19 mm
22 mm
16 Fr
5.3 mm / 6.0 mm
19 mm
24 mm
16 Fr
5.3 mm / 6.0 mm
20 mm
24 mm
16 Fr
5.3 mm / 6.0 mm
21 mm
24 mm
16 Fr
5.3 mm / 6.0 mm
