Device Description; Aortic Main Body And Iliac Leg Components; Main Body Delivery System; Iliac Leg Delivery System - COOK Medical Zenith Alpha Mode D'emploi

ENGLISH
ZENITH ALPHA® ABDOMINAL 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 .
CAUTION: U .S . federal law restricts this device to sale by or on the order
of a physician (or a properly licensed practitioner) .
CAUTION: All contents of the outer pouch (including the introduction
system and endovascular grafts) are supplied sterile, for single use
only .
For the Zenith product line, there are several applicable Suggested
Instructions for Use (IFU) . This IFU describes the Suggested Instructions for
Use for the Zenith Alpha Abdominal Endovascular Graft and Zenith Alpha
Spiral-Z Endovascular Leg (main body, iliac legs, main body extension and
converter) . For information on other Zenith components, please refer to the
following Suggested Instructions for Use:
• Zenith Low Profile AAA/Zenith Alpha Abdominal Ancillary Components;
• Zenith® Branch Endovascular Graft-Iliac Bifurcation;
• Zenith® Renu™ AAA Ancillary Graft;
• Zenith Alpha® Spiral-Z® Endovascular Leg;
• Zenith® Spiral-Z AAA Iliac Leg with the Z-Trak™ Introduction System; and
• Coda® Balloon Catheter .

1 DEVICE DESCRIPTION

1.1 Aortic Main Body and Iliac Leg Components

The Zenith Alpha Abdominal Endovascular Graft is a modular system
consisting of three components: a bifurcated aortic main body and two
iliac legs . (Fig . 1) The graft modules are constructed of woven polyester
fabric sewn to self-expanding nitinol stents with braided polyester and
monofilament polypropylene suture, providing a conduit that is intended
to exclude the aneurysm from blood flow . The modules are fully stented to
provide stability and the expansile force necessary to open the lumen of
the graft during deployment . Additionally, the stents provide the necessary
attachment and seal of the graft to the vessel wall .
The bare suprarenal stent at the proximal end of the graft contains barbs
for additional fixation of the device . To facilitate fluoroscopic visualization
of the stent graft, gold radiopaque markers are positioned on both the
main body and iliac leg components . On the main body, four gold markers
are positioned in a circumferential orientation within 2 mm of the most
superior aspect of the graft material, a checkmark (√) is positioned on the
lateral aspect of the most distal stent of the contralateral limb, and two gold
markers are positioned on the most distal stent of the ipsilateral limb . A
marker also is positioned at the bifurcation of the graft .
On each iliac leg graft there are three gold markers, as explained below:
Proximal Marker 1
Proximal Marker 2
Distal Marker

1.2 Main Body Delivery System

The Zenith Alpha Abdominal Endovascular Graft main body is shipped
preloaded onto an introduction system . (Fig . 2) It has a sequential
deployment method with built-in features to provide continuous control
of the endovascular graft throughout the deployment procedure . The
introduction system is designed for precise positioning and allows
readjustment of the final graft position before deployment of the barbed
suprarenal stent .
The main body graft is loaded on a 16 Fr (6 .0 mm OD) or a 17 Fr (6 .5 mm
OD) introduction system . The proximal bare stent and ipsilateral limb of
the endovascular graft are tethered to the delivery system by wires, which
are integrated into the handle and connected to dual locking mechanisms .
When these locking mechanisms are unlocked and the handle is rotated, the
wires are retracted into the handle and the graft is released in a controlled,
sequential manner . All systems are compatible with a .035 inch wire guide .
The main body graft delivery system features a Flexor introducer sheath
with a Captor Hemostatic Valve . For added hemostasis, the Captor
Hemostatic Valve can be loosened or tightened for the introduction and/
or removal of ancillary devices into and out of the sheath . A Captor Sleeve
is located on the back end of the Captor Hemostatic Valve . This sleeve is
intended to reduce the force required to retract the sheath and withdraw
the gray positioner . The Flexor introducer sheath resists kinking and is
hydrophilically coated . Both features are intended to enhance trackability in
the iliac arteries and abdominal aorta .

1.3 Iliac Leg Delivery System

The Zenith Alpha Spiral-Z Endovascular Legs are shipped preloaded onto an
introduction system . (Fig . 3) The introduction system is designed for ease of
use with minimal preparation and uses a 12 Fr (4 .7 mm OD) or 14 Fr (5 .3 mm
OD) introducer . All systems are compatible with a .035 inch wire guide .
For added hemostasis, the Captor Hemostatic Valve can be loosened or
tightened for the introduction and/or removal of ancillary devices into
and out of the sheath . In addition, 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 .
1.4 Zenith Low Profile AAA/Zenith Alpha Abdominal Ancillary
Components
Zenith Low Profile AAA/Zenith Alpha Abdominal ancillary components are
compatible with the Zenith Low Profile AAA Endovascular Graft, as well as
the Zenith Alpha Abdominal Endovascular Graft .
Additional ancillary endovascular components (main body extensions,
converters) are available . (Fig . 4) Ancillary components are constructed from
woven polyester fabric, self-expanding nitinol stents (main body extensions
Location
Proximal edge
16 mm from proximal edge
Distal edge
and converters), and braided polyester and polypropylene suture, providing
a conduit that is intended to exclude the aneurysm from blood flow .
The aortic main body extensions can be used to provide additional length
to the proximal portion of the endovascular graft . The converters can be
used to convert a bifurcated graft into an AUI graft, if necessary (e .g ., cases
of Type III endoleak, limb occlusion or unattainable contralateral limb
cannulation) . Additional iliac leg components can also be used as ancillary
components to provide additional length to the distal iliac portion of the
graft system .

1.4.1 Main Body Extensions

Main body extensions utilize 16 Fr (6 .0 mm OD) or 17 Fr (6 .5 mm OD)
introduction systems . (Fig . 40) The main body extension introduction
system contains a single trigger-wire release mechanism . Deployment of
the main body extension is achieved by sheath retraction and removing the
distal trigger-wire .
To facilitate fluoroscopic visualization of the stent grafts, the main
body extensions have four gold radiopaque markers positioned in a
circumferential orientation within 2 mm of the most superior aspect of the
graft material .
For added hemostasis, the Captor Hemostatic Valve can be loosened or
tightened for the introduction and/or removal of ancillary devices into
and out of the sheath . The main body extension 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 .

1.4.2 Converters

Converters utilize 16 Fr (6 .0 mm OD) or 17 Fr (6 .5 mm OD) introduction
systems . (Fig . 30) The converter introduction system contains a single
trigger-wire release mechanism . Deployment of the converter is achieved by
sheath retraction and removing the distal trigger-wire .
The converter has a single gold radiopaque marker positioned within 2 mm
of the most superior aspect of the graft material . For added hemostasis, the
Captor Hemostatic Valve can be loosened or tightened for the introduction
and/or removal of ancillary devices into and out of the sheath . The converter
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 .

2 INDICATIONS FOR USE

The Zenith Alpha Abdominal Endovascular Graft is indicated for the
endovascular treatment of patients with abdominal aortic or aorto-iliac
aneurysms having morphology suitable for endovascular repair, including:
• lIiofemoral access vessel size and morphology (minimal thrombus,
calcification and/or tortuosity) should be compatible with a 16 Fr
(6 .0 mm OD) or 17 Fr (6 .5 mm OD) vascular introducer sheath;
• Non-aneurysmal infrarenal aortic segment (neck) proximal to the
aneurysm:
• with a length of at least 15 mm,
• with a diameter measured outer wall to outer wall of no greater than
32 mm and no less than 18 mm,
• with an angle less than 60 degrees relative to the long axis of the
aneurysm, and
• with an angle less than 45 degrees relative to the axis of the suprarenal
aorta .
• Iliac artery distal fixation site greater than 10 mm in length and 8 to
20 mm in diameter (measured outer wall to outer wall) .

3 CONTRAINDICATIONS

The Zenith Alpha Abdominal Endovascular Graft is contraindicated in:
• Patients with known sensitivities or allergies to stainless steel, nitinol,
polyester, polypropylene, urethane, PTFE, nylon or gold .
• Patients with a systemic infection who 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 .
• Always have a qualified surgery team available during implantation or
reintervention procedures in the event that conversion to open surgical
repair is necessary .
• The Zenith Alpha Abdominal Endovascular Graft and introduction
system should only be used by physicians and teams trained in vascular
interventional techniques (catheter-based and surgical) and in the use of
this device . Specific training expectations are described in Section 9 .1,
Physician Training .
• Additional endovascular interventions 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 or migration 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 .
• When a 42 or 59 mm leg graft is used on the ipsilateral side, contralateral
leg overlap into the contralateral main body limb should be limited to
16 mm . Failure to do so may result in occlusion of the ipsilateral limb .
• In the event that the Main Body Release troubleshooting is necessary, as
identified in section 12 it is critical that the user unlock the gray safety
lock knob prior to execution .

4.2 Patient Selection, Treatment and Follow-Up

• The Zenith Alpha Abdominal Endovascular Graft is designed to treat
aortic neck diameters no smaller than 18 mm and no larger than
32 mm . The Zenith Alpha Abdominal Endovascular Graft is designed to
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