Zenith® Universal Distal Body Endovascular Graft; Device Description; Overall Device Description; Implant - COOK Medical Zenith Universal Distal Body Mode D'emploi

ENGLISH
ZENITH® UNIVERSAL DISTAL BODY
ENDOVASCULAR GRAFT
Read all instructions carefully. Failure to properly follow the
instructions, warnings and precautions may lead to serious surgical
consequences or injury to the patient.
For the Zenith product line, there are several applicable Instructions
for Use (IFU). This IFU describes the Zenith Universal Distal Body
Endovascular Graft. For information on other Zenith devices, please
refer to the appropriate Instructions for Use.

1 DEVICE DESCRIPTION

1.1 Overall Device Description

The Zenith Universal Distal Body Endovascular Graft (Zenith Universal
Distal Body) consists of an implant loaded into a delivery system. The
device is designed to be used in combination with other Zenith proximal
grafts (for example, Zenith® t-Branch Thoracoabdominal Endovascular
Graft (t-Branch) or Zenith® Fenestrated AAA Endovascular Graft (ZFEN-P))
and Iliac Leg Grafts (e.g., Zenith® Flex AAA Endovascular Graft Iliac Leg or
Zenith Spiral-Z AAA Iliac Leg). Refer to Figure 1.

1.2 Implant

The Zenith Universal Distal Body implant is a bifurcated endovascular
graft with one long ipsilateral iliac limb and one short contralateral
iliac limb. The graft is constructed of woven polyester fabric sewn to
self-expanding stainless steel Cook Z-Stents® with braided polyester and
mono lament polypropylene suture. The graft is fully stented to provide
stability and the expansile force necessary to open the lumen of the graft
during deployment. Refer to Figure 2.
The Zenith Universal Distal Body graft is intended to work as a modular
system in combination with other available Zenith proximal devices (e.g.
Zenith t-Branch) and iliac leg grafts (e.g. Zenith Flex AAA Endovascular
Graft Iliac Leg, Zenith Spiral-Z AAA Iliac Leg).
Devices such as main body extensions, iliac leg extensions, converters,
and iliac plugs may also be required during an aortic endovascular
procedure. Each individual device has its own delivery system and
Instructions for Use booklet.

1.2.1 Implant Sizes and Configurations

A range of proximal graft diameters and graft lengths are available to
accommodate a range of Zenith proximal devices and to suit individual
patient anatomies. Available sizes include a proximal graft diameter of 22
and 24 mm each with lengths of 81, 98, 115 and 132 mm.

1.2.2 Gold Marker Placement

To facilitate uoroscopic visualisation, gold radiopaque markers
are positioned on the graft. Four gold markers are positioned in a
circumferential orientation within 2 mm of the most superior aspect of
the graft material (proximal markers) and one gold marker is positioned
at the end of the second proximal stent to aid with overlap positioning.
There is a radiopaque marker at the graft bifurcation and gold markers
are positioned in the shape of a tick (check) marker on the distal end of
the contralateral limb. Refer to Figure 3.

1.3 Delivery System

The Zenith Universal Distal Body graft is shipped loaded onto the
H&L-B One-Shot Introduction System. It has a sequential deployment
method with built-in features to provide continuous control of the graft
throughout the deployment procedure.
The proximal end of the graft is attached to the delivery system by three
nitinol trigger wires. The distal end of the graft is also attached to the
delivery system and held by an independent stainless steel trigger-wire.
The trigger wires enable precise positioning and allow readjustment of
the nal graft position before full deployment.
The delivery system uses a 7.7 mm O.D. (20 Fr) H&L-B One-Shot
Introduction System and is compatible with a 0.89 mm (0.035 inch) wire
guide.
For added haemostasis, the Captor Haemostatic Valve can be opened or
closed for the introduction and/or removal of other devices into and out
of the sheath. The delivery system features a Flexor® introducer sheath
which resists kinking and is hydrophilically coated. Both features are
intended to enhance trackability in the iliac arteries and abdominal aorta.
Refer to Figure 4.
1.4 Devices used In Combination with the Zenith Universal
Distal Body
The Zenith Universal Distal Body can be used in conjunction with other
approved Zenith devices. Examples include the following:
Zenith t-Branch Thoracoabdominal Endovascular Graft
Zenith Fenestrated AAA Endovascular Graft
Zenith Flex AAA Endovascular Graft Iliac Leg
Zenith Spiral-Z AAA Iliac Leg.
Refer to the respective Instructions for Use for any of these devices.

2 INDICATIONS FOR USE

The Zenith Universal Distal Body Endovascular Graft is indicated for the
endovascular treatment of patients with abdominal or thoracoabdominal
aortic aneurysms, when used with the appropriate Zenith proximal
device and Zenith iliac leg grafts.
The patient must have anatomy suitable for endovascular repair,
including:
Adequate femoral/iliac access compatible with the required delivery
systems;
An appropriate length of abdominal aorta, distal from the most
proximal point of the overlap with the proximal piece to the aortic
bifurcation.

3 CONTRAINDICATIONS

The Zenith Universal Distal Body Endovascular Graft is contraindicated in:
Patients with known sensitivities or allergies to stainless steel, nitinol,
polyester, solder (tin, silver), polypropylene, urethane or gold
Patients with a systemic infection may be at increased risk of
endovascular graft infection.

4 WARNINGS AND PRECAUTIONS

4.1 General

Read all instructions carefully. Failure to properly follow the
instructions, warnings and precautions may lead to serious
consequences or injury to the patient.
The Zenith Universal Distal Body should only be used by physicians and
teams trained in vascular interventional techniques and in the use of
this device. Specific training expectations are described in Section 9.1,
Physician Training.
Lack of non-contrast CT imaging may result in failure to appreciate iliac
or aortic calcification, which may preclude access or reliable device
fixation and seal.
Pre-procedure imaging reconstruction thicknesses >3 mm may result
in sub-optimal device sizing, or in failure to appreciate focal stenosis
from CT.
The long-term performance of endovascular grafts has not yet been
established. All patients should be advised that endovascular
treatment requires life-long, regular follow-up to assess their health
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.
After endovascular graft placement, patients should be regularly
monitored for perigraft flow, aneurysm growth or changes in the
structure or position of the endovascular graft. At a minimum, annual
imaging is required, including:
1) abdominal radiographs to examine device integrity (separation
between components, stent fracture or barb separation) and;
2) contrast and non-contrast CT to examine aneurysm changes,
perigraft ow, patency, tortuosity and progressive disease.
If renal complications or other factors preclude the use of image
contrast media, abdominal radiographs and duplex ultrasound may
provide similar information.
The Zenith Universal Distal Body is not recommended in patients
unable to undergo, or who will not be compliant with the necessary
preoperative and post-operative imaging and implantation studies as
described in Section 11, Imaging Guidelines and Post-Operative
Follow-Up.
Intervention or conversion to standard open surgical repair following
initial endovascular repair should be considered for patients
experiencing enlarging aneurysms, unacceptable decrease in fixation
length (vessel and component overlap) and/or endoleak. An increase in
aneurysm size and/or persistent endoleak may lead to aneurysm
rupture.
Patients experiencing reduced blood flow through the graft limb and/
or leaks may be required to undergo secondary interventions or
surgical procedures.
A vascular surgery team should always be made available during
implantation or reintervention procedures in the event that conversion
to open surgical repair is necessary.

4.2 Patient Selection, Treatment and Follow-Up

The Zenith Universal Distal Body has not been evaluated in the following
patient populations:
Traumatic aortic injury
Leaking, pending rupture or ruptured aneurysms
Mycotic aneurysms
Pseudoaneurysms resulting from previous graft placement
Revision of previously placed endovascular grafts
Uncorrectable coagulopathy
Indispensable inferior mesenteric artery
Genetic connective tissue disease (e.g., Marfan's or Ehlers-Danlos
Syndromes)
Concomitant thoracic aortic aneurysms
Patients with active systemic infections
Pregnant or nursing females
Morbidly obese patients
Less than 18 years of age.
Access vessel diameter (measured inner wall to inner wall) and
morphology (minimal tortuosity, occlusive disease and/or calci cation)
should be compatible with vascular access techniques and delivery
systems of the pro le of a 7.7 mm OD (20 Fr) to 8.5 mm OD (22 Fr) vascular
introducer sheath. Vessels that are signi cantly calci ed, occlusive,
tortuous or thrombus-lined may preclude placement of the endovascular
graft and/or may increase the risk of embolisation.
Key anatomic elements that may adversely a ect successful exclusion
of the aneurysm include severe aortic angulation, tortuosity and
calci cation.
The Zenith Universal Distal Body is not recommended in patients who
cannot tolerate contrast agents necessary for intra-operative and post-
operative follow-up imaging.
The Zenith Universal Distal Body is not recommended in patients
exceeding weight and/or size limits which compromise or prevent the
necessary imaging requirements.
The Zenith Universal Distal Body is not recommended in patients with
known sensitivities or allergies to stainless steel, polyester, solder (tin,
silver), polypropylene, urethane or gold.
Patients with a systemic infection may be at increased risk of
endovascular graft infection.
Inability to maintain patency of at least one internal iliac artery or
occlusion of an indispensable inferior mesenteric artery may increase the
risk of pelvic/bowel ischemia.
Patients with uncorrectable coagulopathy may have an increased risk of
endoleak or bleeding complications.

4.3 Implant Procedure Requirements

Systemic anticoagulation should be used during the implantation
procedure based on hospital and physician preferred protocol. If
heparin is contraindicated, an alternative anticoagulant should be
considered.
Minimize handling of the constrained endoprosthesis during
preparation and insertion to decrease the risk of endoprosthesis
contamination and infection.
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