Device Description; Proximal Body Graft; Proximal Body Graft Delivery System; Distal Bifurcated Body Graft - COOK Medical Zenith Fenestrated Mode D'emploi

ENGLISH
ZENITH® FENESTRATED AAA ENDOVASCULAR GRAFT WITH THE
H&L-B ONE-SHOT™ INTRODUCTION SYSTEM
Read all instructions carefully. Failure to properly follow the instructions,
warnings, and precautions may lead to serious consequences or injury to
the patient.

1 DEVICE DESCRIPTION

The Zenith Fenestrated AAA Endovascular Graft is a modular system
consisting of three components, a proximal body graft, a distal bifurcated
body graft and one iliac leg. (Figure 1) The graft modules are constructed
of full-thickness woven polyester fabric sewn to self-expanding
stainless steel Cook-Z® stents with braided polyester and mono lament
polypropylene suture.
The modules are fully stented to provide stability and the expansile force
necessary to open the lumen of the graft during deployment. Additionally,
the Cook-Z stents provide the necessary attachment and seal of the graft
to the vessel wall.
Ancillary devices such as main body extensions, iliac leg extensions,
converters, and iliac plugs may also be required.
Each individual device has its own separate delivery system.
Each component comes in a range of lengths and diameters which allows
the physician to tailor the device to individual patient anatomies and select
the best proximal and distal xation sites.

1.1 Proximal Body Graft

The bare suprarenal stent at the proximal end of the proximal body graft
contains barbs that are placed at 3 mm increments for additional xation
of the device. This graft contains up to three precisely located holes
(fenestration(s)), and cut-outs from the proximal margin (scallop(s)) of the
graft material. (Figure 2)
The purpose of these scallops and fenestrations is to allow the proximal
margin of the device to sit higher than standard AAA devices and allow
uninterrupted blood ow to branch vessels of the aorta such as the renal
and superior mesenteric arteries.
To facilitate uoroscopic visualisation of the stent graft, gold radiopaque
markers are positioned as follows: one on the lateral aspect of the most
distal stent and four in a circumferential orientation within 1 mm of the
most superior aspect of the graft material.
To facilitate orientation of the graft during deployment gold radiopaque
markers are positioned on the anterior and posterior surfaces of the graft,
below the level of the fenestrations. Additional gold markers are positioned
anteriorly in the shape of a tick or check marker.

1.2 Proximal Body Graft Delivery System

The Zenith Fenestrated AAA Endovascular Proximal Body Graft is shipped
preloaded onto the H&L-B One-Shot Introduction System. (Figure 3)
It has sequential deployment method with built-in features to provide
continuous control of the graft throughout the deployment procedure.
The graft is reduced in diameter by an independent wire tied to diameter
reducing ties, which allows the graft to be manipulated within the aorta to
allow accurate positioning of the graft, which enables the fenestration(s) to
line up with the desired arteries.
The bare suprarenal stent is constrained within a top cap and held by a
trigger-wire. The distal end of the graft is also attached to the delivery
system and held by an independent wire. The H&L-B One-Shot Introduction
System enables precise positioning and allows readjustment of the nal
graft position before deployment of the bare barbed suprarenal stent.
The delivery system uses a 6.7 mm I.D. (20 French) or 7.3 mm I.D. (22 French)
H&L-B One-Shot Introduction System. All Systems are compatible with a
.035 inch (0.89 mm) wire guide.
For added hemostasis, the Captor® Hemostatic Valve can be opened or
closed for the introduction and/or removal of ancillary devices into and out
of the sheath. The proximal body graft 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.

1.3 Distal Bifurcated Body Graft

The Zenith Fenestrated AAA Endovascular Distal Bifurcated Body Graft has
one long ipsilateral iliac limb and one short contralateral limb. To facilitate
uoroscopic visualisation of the stent graft, there is a radiopaque marker
at the graft bifurcation and a contralateral limb radiopaque marker at the
distal end of the contralateral limb. (Figure 4)

1.4 Distal Bifurcated Body Graft Delivery System

The Zenith Fenestrated AAA Endovascular Distal Bifurcated Body Graft is
shipped preloaded onto the H&L-B One-Shot Introduction System. (Figure 5)
The bifurcated graft has one long ipsilateral limb and one short
contralateral limb. There is a radiopaque marker at the graft bifurcation and
a radiopaque marker at the distal end of the contralateral limb. It has a
sequential deployment method with built-in features to provide
continuous control of the graft throughout the deployment procedure.
Both the proximal and distal segments of the graft are attached to the
delivery system and held by independent wires.
The H&L-B One Shot Introduction System enables precise positioning and
allows readjustment of the graft position before deployment of the graft.
The delivery system uses a 6.7 mm I.D. (20 French) H&L-B One-Shot
Introduction System. All systems are compatible with a .035 inch (0.89 mm)
wire guide.
For added hemostasis, the Captor Hemostatic Valve can be opened or
closed for the introduction and/or removal of ancillary devices into and out
of the sheath. The distal bifurcated body graft 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.

1.5 Iliac Leg

The Zenith Fenestrated AAA Endovascular Graft includes a Zenith iliac leg
graft component. Examples include the Zenith Spiral-Z AAA Iliac Leg (ZSLE).
Refer to the respective Instructions for Use.
All iliac leg delivery systems use a 4.7 mm I.D. (14 French) or 5.3 mm I.D. (16
French) Introduction System. All systems are compatible with a .035 inch
(0.89 mm) wire guide system and are designed for ease of use with minimal
preparation.

1.6 Ancillary Components

Additional ancillary components (main body extensions, iliac leg
extensions, converters, and iliac plugs) are available. (Figure 6)
Zenith ancillary components are constructed from the same polyester
fabric, self-expanding stainless steel Cook-Z stents, and polypropylene
suture used in constructing the principal graft modules. Refer to
Instructions for Use enclosed in device packaging.

2 INTENDED USE

The Zenith Fenestrated AAA Endovascular Graft with the H&L-B One-Shot
Introduction System is indicated for the treatment of infrarenal abdominal
aortic aneurysms (AAAs) in high-risk patients who are not suitable for
conventional open surgical repair or who are not suitable for repair with a
standard Zenith Endovascular Graft, when the aneurysmal disease extends
up to the level of the renal arteries.
The patient must have aneurysmal morphology suitable for endovascular
repair, including:
• Adequate femoral/iliac access compatible with the required delivery
systems;
• A non-aneurysmal infrarenal aortic segment (neck) proximal to the
aneurysm with:
• A length of at least 4 mm, i.e. at least 4 mm circumferential wall
contact around fenestrations and/or limits of scallop;
• A diameter measured outer wall to outer wall of no greater than 31mm
and no less than 19 mm;
• An angle less than 45 degrees relative to the long axis of the aneurysm;
and
• An angle less than 45 degrees relative to the axis of the suprarenal
aorta.
• An ipsilateral iliac artery distal fixation site greater than 10 mm in length
and 9–21 mm in diameter (measured outer wall to outer wall); and
• A contralateral iliac artery distal fixation site greater than 10 mm in length
and 7–21 mm in diameter (measured outer wall to outer wall).

3 CONTRAINDICATIONS

There are no known contraindications for these devices.

4 WARNINGS AND PRECAUTIONS

4.1 General Use Information

• Read all instructions carefully. Failure to properly follow the instructions,
warnings and precautions may lead to serious consequences or injury to
the patient.
• Fenestrated grafts are made to a customised design to a specification
requested by the responsible Physician, and are tailored to a specific
patient's anatomy.
• 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.
• 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.
• Preprocedure imaging reconstruction thickness > 3 mm may result in
sub-optimal device sizing, or in failure to appreciate focal stenosis from
CT
• The long-term performance and safety of endovascular grafts has
not yet been established. As a result, life-long, regular follow-up must
be undertaken in all patients to assess the ongoing performance of the
Zenith Fenestrated AAA 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.
• 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 flow,
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 Fenestrated AAA Endovascular Graft with the H&L-B One-Shot
Introduction System 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.
• Always have a vascular surgery team available during implantation or
reintervention procedures in the event that conversion to open surgical
repair is necessary.
• 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
specifically relevant during and after manipulation of the grey positioner.
After the grey positioner has been removed, if blood loss is excessive,
consider placing an uninflated moulding balloon or an introduction
system dilator within the valve, restricting flow.

4.2 Patient Selection, Treatment and Follow-Up

• Access vessel diameter (measured inner wall to inner wall) and
morphology (minimal tortuosity, occlusive disease, and/or calcification)
should be compatible with vascular access techniques and delivery
systems of the profile of a 5.5 mm O.D. (14 French) to 8.6 mm O.D.
(22 French) vascular introducer sheath.
Vessels that are significantly calcified, 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 affect successful exclusion of the
aneurysm include severe proximal neck angulation (> 45 degrees for
infrarenal neck to axis of AAA or > 45 degrees for suprarenal neck relative
to the immediate infrarenal neck); short proximal aortic neck (< 4 mm);
greater than 10% increase in diameter over 15 mm of proximal aortic
neck length; and circumferential thrombus and/or calcification at the
arterial implantation sites, specifically the proximal aortic neck and distal
iliac artery interface.
Irregular calcification and/or plaque may compromise the fixation and
sealing of the implantation sites. Necks exhibiting these key anatomic
elements may be more conducive to graft migration.
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