Distal Bifurcated Body Graft; Clinical Use Information; Physician Training; Inspection Prior To Use - COOK Medical Zenith Fenestrated Mode D'emploi

Reorder Ipsilateral Leg
Number Diameter
ZFEN-D-12-28-76 12 mm
ZFEN-D-16-28-76 16 mm
ZFEN-D-20-28-76 20 mm
ZFEN-D-12-28-94 12 mm
ZFEN-D-16-28-94 16 mm
ZFEN-D-20-28-94 20 mm
ZFEN-D-12-28-109 12 mm
ZFEN-D-16-28-109 16 mm
ZFEN-D-20-28-109 20 mm
ZFEN-D-12-28-124 12 mm
ZFEN-D-16-28-124 16 mm
ZFEN-D-20-28-124 20 mm
ZFEN-D-12-45-76 12 mm
ZFEN-D-16-45-76 16 mm
ZFEN-D-20-45-76 20 mm
ZFEN-D-24-45-76 24 mm
ZFEN-D-12-45-94 12 mm
ZFEN-D-16-45-94 16 mm
ZFEN-D-20-45-94 20 mm
ZFEN-D-24-45-94 24 mm
ZFEN-D-12-45-109 12 mm
ZFEN-D-16-45-109 16 mm
ZFEN-D-20-45-109 20 mm
ZFEN-D-24-45-109 24 mm
ZFEN-D-12-45-124 12 mm
ZFEN-D-16-45-124 16 mm
ZFEN-D-20-45-124 20 mm
ZFEN-D-24-45-124 24 mm
ZFEN-D-12-62-76 12 mm
ZFEN-D-16-62-76 16 mm
ZFEN-D-20-62-76 20 mm
ZFEN-D-24-62-76 24 mm
ZFEN-D-12-62-94 12 mm
ZFEN-D-16-62-94 16 mm
ZFEN-D-20-62-94 20 mm
ZFEN-D-24-62-94 24 mm
ZFEN-D-12-62-109 12 mm
ZFEN-D-16-62-109 16 mm
ZFEN-D-20-62-109 20 mm
ZFEN-D-24-62-109 24 mm
ZFEN-D-12-62-124 12 mm
ZFEN-D-16-62-124 16 mm
ZFEN-D-20-62-124 20 mm
ZFEN-D-24-62-124 24 mm

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:
• Knowledge of the natural history of abdominal aortic aneurysms (AAA)
and co-morbidities associated with AAA repair.
• Knowledge of radiographic image interpretation, device selection and
sizing.
A multi-disciplinary team that has combined procedural experience
with:
• Femoral cutdown, arteriotomy and repair
• Percutaneous access and closure techniques
• Non-selective and selective wire guide and catheter techniques
• Fluoroscopic and angiographic image interpretation
• Embolisation
• Angioplasty
• Endovascular stent placement
• Snare techniques
• Appropriate use of radiographic contrast material
• Techniques to minimise 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 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)
have been supplied for the patient by matching the device to the order
prescribed by the physician for that particular patient.

8.2 Distal Bifurcated Body Graft

Distal Body Distal Leg
Length Length French Size
76 mm 28 mm
76 mm 28 mm
76 mm 28 mm
94 mm 28 mm
94 mm 28 mm
94 mm 28 mm
109 mm 28 mm
109 mm 28 mm
109 mm 28 mm
124 mm 28 mm
124 mm 28 mm
124 mm 28 mm
76 mm 45 mm
76 mm 45 mm
76 mm 45 mm
76 mm 45 mm
94 mm 45 mm
94 mm 45 mm
94 mm 45 mm
94 mm 45 mm
109 mm 45 mm
109 mm 45 mm
109 mm 45 mm
109 mm 45 mm
124 mm 45 mm
124 mm 45 mm
124 mm 45 mm
124 mm 45 mm
76 mm 62 mm
76 mm 62 mm
76 mm 62 mm
76 mm 62 mm
94 mm 62 mm
94 mm 62 mm
94 mm 62 mm
94 mm 62 mm
109 mm 62 mm
109 mm 62 mm
109 mm 62 mm
109 mm 62 mm
124 mm 62 mm
124 mm 62 mm
124 mm 62 mm
124 mm 62 mm

9.3 Materials Required

(Not included in 3-piece modular system)
• Zenith AAA Endovascular Graft Ancillary Kit
• Fluoroscope with digital angiography capabilities (C-arm or fixed unit)
• Contrast media
• Syringe
• Heparinised saline solution

9.4 Materials Recommended

(Not included in 3-piece modular system)
The following products are recommended:
• .035 inch (0.89 mm) extra stiff wire guide, 260 cm; for example:
• Cook Amplatz Ultra Stiff Wire Guides (AUS)
• Cook Lunderquist Extra Stiff Wire Guides (LES)
• .035 inch (0.89 mm) standard wire guide; for example:
• Cook .035 inch wire guides
• Cook Nimble™ Wire Guides
• Molding Balloons
• Introducer sets; for example:
• Cook Check-Flo® Introducer Sets
• Cook Extra Large Check-Flo Introducer Sets
• Cook Flexor Balkin Up & Over® Contralateral Introducers
• Cook Flexor Guiding Sheaths
• Sizing catheter; for example:
• Cook Aurous® Centimeter Sizing Catheters
• Angiographic radiopaque tip catheters; for example:
• Cook Beacon® Tip Angiographic Catheters
• Cook Royal Flush® Catheters with Beacon Tip
• Entry needles; for example:
• Cook single wall entry needles

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.
29
Introduction Sheath Introduction Sheath
(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
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
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
Length
40 cm
40 cm
40 cm
40 cm
40 cm
40 cm
40 cm
40 cm
40 cm
40 cm
40 cm
40 cm
40 cm
40 cm
40 cm
40 cm
40 cm
40 cm
40 cm
40 cm
40 cm
40 cm
40 cm
40 cm
40 cm
40 cm
40 cm
40 cm
40 cm
40 cm
40 cm
40 cm
40 cm
40 cm
40 cm
40 cm
40 cm
40 cm
40 cm
40 cm
40 cm
40 cm
40 cm
40 cm