Clinical Use Information; Physician Training; Inspection Prior To Use; Materials Required - COOK Medical Zenith Fenestrated AAA Instructions For Use Manual

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:
and co-morbidities associated with AAA repair.
sizing.
A multi-disciplinary team that has combined procedural experience
with:

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 o ce
or Representative. Prior to use, verify correct devices (quantity and size)
Intended Aortic
Vessel Diameter
19 mm
20 mm
21 mm
21 mm
22 mm
23 mm
24 mm
24 mm
25 mm
26 mm
26 mm
27 mm
28 mm
28 mm
29 mm
29 mm
30 mm
31 mm
Intended Iliac
Vessel Diameter
9 mm
10 mm
11 mm
12 mm
13 mm
14 mm
15 mm
15 mm
16 mm
17 mm
18 mm
18 mm
19 mm
20 mm
21 mm
Intended Iliac
Vessel Diameter
7 mm
8 mm
9 mm
9 mm
10 mm
11 mm
12 mm
13 mm
13 mm
14 mm
15 mm
15 mm
16 mm
16 mm
17 mm
17 mm
18 mm
18 mm
19 mm
19 mm
20 mm
21 mm
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)

9.4 Materials Recommended

(Not included in 3-piece modular system)
The following products are recommended:

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 ow.

9.5.1 Proximal Body Graft Diameter Sizing

Main Body
Diameter
24 mm
24 mm
24 mm
26 mm
26 mm
28 mm
28 mm
30 mm
30 mm
30 mm
32 mm
32 mm
32 mm
34 mm
34 mm
36 mm
36 mm
36 mm

9.5.2 Distal Ipsilateral Graft Diameter Sizing

Ipsilateral
Fenestrated Leg
12 mm
12 mm
12 mm
16 mm
16 mm
16 mm
16 mm
20 mm
20 mm
20 mm
20 mm
24 mm
24 mm
24 mm
24 mm

9.5.3 Iliac Leg Graft Diameter Sizing

Iliac Leg
Diameter
8 mm
10 mm
10 mm
12 mm
12 mm
12 mm
14 mm
14 mm
16 mm
16 mm
16 mm
18 mm
18 mm
20 mm
18 mm
20 mm
20 mm
22 mm
22 mm
24 mm
24 mm
24 mm
30
Introduction Sheath
French Size (I.D. / O.D.)
20 Fr 6.7 mm / 7.7 mm
20 Fr 6.7 mm / 7.7 mm
20 Fr 6.7 mm / 7.7 mm
20 Fr 6.7 mm / 7.7 mm
20 Fr 6.7 mm / 7.7 mm
20 Fr 6.7 mm / 7.7 mm
20 Fr 6.7 mm / 7.7 mm
20 Fr 6.7 mm / 7.7 mm
20 Fr 6.7 mm / 7.7 mm
20 Fr 6.7 mm / 7.7 mm
20 Fr 6.7 mm / 7.7 mm
20 Fr 6.7 mm / 7.7 mm
20 Fr 6.7 mm / 7.7 mm
20 Fr 6.7 mm / 7.7 mm
20 Fr 6.7 mm / 7.7 mm
22 Fr 7.3 mm / 8.5 mm
22 Fr 7.3 mm / 8.5 mm
22 Fr 7.3 mm / 8.5 mm
Introduction Sheath
French Size (I.D. / O.D.)
20 Fr 6.7 mm / 7.7 mm
20 Fr 6.7 mm / 7.7 mm
20 Fr 6.7 mm / 7.7 mm
20 Fr 6.7 mm / 7.7 mm
20 Fr 6.7 mm / 7.7 mm
20 Fr 6.7 mm / 7.7 mm
20 Fr 6.7 mm / 7.7 mm
20 Fr 6.7 mm / 7.7 mm
20 Fr 6.7 mm / 7.7 mm
20 Fr 6.7 mm / 7.7 mm
20 Fr 6.7 mm / 7.7 mm
20 Fr 6.7 mm / 7.7 mm
20 Fr 6.7 mm / 7.7 mm
20 Fr 6.7 mm / 7.7 mm
20 Fr 6.7 mm / 7.7 mm
Introduction Sheath
French Size (I.D. / O.D.)
14 Fr 4.7 mm / 5.3 mm
14 Fr 4.7 mm / 5.3 mm
14 Fr 4.7 mm / 5.3 mm
14 Fr 4.7 mm / 5.3 mm
14 Fr 4.7 mm / 5.3 mm
14 Fr 4.7 mm / 5.3 mm
14 Fr 4.7 mm / 5.3 mm
14 Fr 4.7 mm / 5.3 mm
14 Fr 4.7 mm / 5.3 mm
14 Fr 4.7 mm / 5.3 mm
14 Fr 4.7 mm / 5.3 mm
16 Fr 5.3 mm / 6.0 mm
16 Fr 5.3 mm / 6.0 mm
16 Fr 5.3 mm / 6.0 mm
16 Fr 5.3 mm / 6.0 mm
16 Fr 5.3 mm / 6.0 mm
16 Fr 5.3 mm / 6.0 mm
16 Fr 5.3 mm / 6.0 mm
16 Fr 5.3 mm / 6.0 mm
16 Fr 5.3 mm / 6.0 mm
16 Fr 5.3 mm / 6.0 mm
16 Fr 5.3 mm / 6.0 mm