How Supplied; General; Device Sizes And Sizing Guidelines; Device Options - COOK Medical Zenith Universal Distal Body Mode D'emploi

and the performance of their 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.
Patients should be counseled on the importance of adhering to the
follow-up schedule, both during the first year and at yearly intervals
thereafter. Patients should be told that regular and consistent follow-
up is a critical part of ensuring the ongoing safety and effectiveness of
endovascular treatment of abdominal aortic aneurysms (AAA) or
thoracoabdominal aortic aneurysms (TAAA). At a minimum, annual
imaging and adherence to routine post-operative follow-up
requirements is required and should be considered a life-long
commitment to the patient's health and well-being.
Physicians must advise all patients that it is important to seek prompt
medical attention if he/she experiences signs of limb occlusion,
aneurysm enlargement or rupture. Signs of graft limb occlusion include
pain in the hip(s) or leg(s) during walking or at rest or discoloration or
coolness of the leg. Aneurysm rupture may be asymptomatic, but
usually presents as: pain; numbness; weakness in the legs; any back,
chest, abdominal or groin pain; dizziness; fainting; rapid heartbeat or
sudden weakness.

8 HOW SUPPLIED

8.1 General

The Zenith Universal Distal Body is supplied STERILE (100% Ethylene
Oxide) in peel-open pouches (sterile inner pouch).
Proximal
Product Code Diameter
UNIBODY-22-81 22 mm
UNIBODY-22-98 22 mm
UNIBODY-22-115 22 mm
UNIBODY-22-132 22 mm
UNIBODY-24-81 24 mm
UNIBODY-24-98 24 mm
UNIBODY-24-115 24 mm
UNIBODY-24-132 24 mm

8.2.2 Sizing Guidelines

A 2 mm-4 mm interference t, combined with a minimum 2 stent overlap,
is typical in the use of a distal bifurcated endovascular graft with a
proximal component to reduce the risk of component separation.

9 CLINICAL USE INFORMATION

9.1 Physician Training

CAUTION: Always have a vascular surgery team available during
implantation or re-intervention procedures in the event that
conversion to open surgical repair is necessary.
CAUTION: The Zenith Universal Distal Body should only be used by
physicians and teams trained in aortic endovascular interventional
techniques and in the use of this device. The recommended skill/
knowledge requirements for physicians using the Zenith Universal
Distal Body are outlined below:
Patient selection:
Knowledge of the natural history of abdominal aortic aneurysms (AAA)
or thoracoabdominal aortic aneurysms (TAAA) and co-morbidities
associated with endovascular aneurysm 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
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 Cook Medical Australia.
Prior to use, verify correct device (size) has been supplied for the patient
by matching the device to the order prescribed by the physician for
that particular patient. Also ensure the expiration date has not been
surpassed and the device has been stored as per storage conditions
printed on the device label.
The device is to be used in conjunction with materials and devices
outlined in the following sections.

9.3 Materials Required

(Not included in system)
The following products are recommended to assist in the implantation
of the Zenith Universal Distal Body. For information on the use of these
products, refer to the individual product's Instructions for Use:
Fluoroscope with digital angiography capabilities (C-arm or fixed unit)
Contrast media
Syringe
Heparinised saline solution
Sterile gauze pads

9.4 Recommended Devices

(Not included in system)
0.89 mm (0.035") extra stiff wire guide, 260 cm; for example:
Cook Lunderquist Extra Stiff Wire Guides (LES)
0.89 mm (0.035") standard wire guide; for example:
This device is intended for single patient use only. Do not reuse, reprocess
or resterilise any part of this device. Reuse, reprocessing, or resterilisation
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 resterilisation 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 this occurs, return
the device to William A. Cook Australia Pty Ltd.
The label includes the device code, components supplied, expiry date
and storage requirements to be followed for this device.
The device is loaded into a 7.7 mm OD (20 Fr) introducer sheath.
The sheath's surface is treated with a hydrophilic coating that, when
hydrated, enhances trackability.
The device is supplied with a tip protector (tip end), needle hub
protector (handle end) and shipping stylet (handle end) that are to be
removed prior to use.

8.2 Device Sizes and Sizing Guidelines

8.2.1 Device Options

The product code for the Zenith Universal Distal Body Endovascular Graft
is UNIBODY-[D1]-[L1]. All graft options for the Zenith Universal Distal Body
are listed here:
Distal Limb
Length Diameter French Size
81 mm 11 mm
98 mm 11 mm
115 mm 11 mm
132 mm 11 mm
81 mm 12 mm
98 mm 12 mm
115 mm 12 mm
132 mm 12 mm
Cook 0.035 inch wire guides
Cook Nimble™ Wire Guides
Moulding Balloons; for example:
Cook Coda® Balloon Catheter
Introducer sets; for example:
Cook Check-Flo® Introducer Sets
Cook Extra Large Check-Flo® Introducer Sets
Sizing catheter; for example:
Cook Aurous® Centimetre Sizing Catheters
Angiographic radiopaque tip catheters; for example:
Cook Beacon® Tip Angiographic Catheters
Cook Beacon® Tip Royal Flush Catheters
Entry needles; for example:
Cook single wall entry needles.

10 DIRECTIONS FOR USE

Prior to use of the Zenith Universal Distal Body, review this Instructions
for Use booklet. The following instructions embody a basic guideline
for device placement. Variations in the following procedures may be
necessary. These instructions are intended to help guide the physician
and do not take the place of physician judgment.
The suggested general order of implantation is:
1. Zenith Proximal Body Graft
2. Covered Visceral Stents
3. Universal Distal Body Graft
4. Contralateral Iliac Leg or Iliac Device
5. Ipsilateral Iliac Leg or Iliac Device.

10.1 General Use Information

Standard techniques for placement of arterial access sheaths, guiding
catheters, angiographic catheters and wire guides should be employed
during use of the Zenith Universal Distal Body. The Zenith Universal Distal
Body is compatible with 0.89 mm (0.035") diameter wire guides.
Endovascular stent grafting is a surgical procedure and blood loss from
various causes may occur, infrequently requiring intervention (including
transfusion) to prevent adverse outcomes. It is important to monitor
blood loss from the haemostatic valve throughout the procedure, but is
speci cally relevant during and after manipulation of the grey positioner.
After the grey positioner has been removed, if blood loss is excessive
consider placing an unin ated moulding balloon or an introduction
system dilator within the valve, restricting ow.

10.2 Pre-Implant Review

Verify from planning that the correct device has been selected.

10.3 Patient Preparation

1. Refer to institutional protocols relating to anaesthesia,
anticoagulation and monitoring of vital signs.
2. Position patient on imaging table allowing uoroscopic visualisation
from the aortic arch to the femoral bifurcations.
3. Gain access to both femoral arteries using standard surgical
technique or percutaneous technique.
4. Establish adequate proximal and distal vascular control of both
femoral arteries.

10.4 Device Preparation/Flush

1. Remove black-hubbed shipping stylet (from the inner cannula),
cannula protector tube (from the inner cannula) and dilator tip
protector (from the dilator tip). Remove Peel-Away® sheath from back
of the haemostatic valve. See Figure 5.
2. Elevate tip of system and ush through the stopcock on the
haemostatic valve with heparinised saline until uid emerges from
the ushing groove in the tip. Refer to Figure 6. Continue to inject
a full 20 ml of ushing solution through the device. Discontinue
injection and close stopcock on connecting tube.
15
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
Length
40 cm
40 cm
40 cm
40 cm
40 cm
40 cm
40 cm
40 cm