Device Description; Zenith Alpha Thoracic Endovascular Graft; Introduction System; Zenith Alpha Thoracic Endovascular Graft Ancillary Component - COOK Medical Zenith Alpha Mode D'emploi

ENGLISH
ZENITH ALPHA™ THORACIC ENDOVASCULAR
GRAFT
Read all instructions carefully. Failure to properly follow the instructions,
warnings, and precautions may lead to serious 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 inner pouch (including the introduction
system and endovascular graft) are supplied sterile, for single use only.

1 DEVICE DESCRIPTION

1.1 Zenith Alpha Thoracic Endovascular Graft

The Zenith Alpha Thoracic Endovascular Graft is a two-piece cylindrical
endovascular graft consisting of proximal and distal components. The
proximal component can be either tapered or nontapered and may be used
independently (for ulcers/saccular aneurysms) or in combination with a distal
component. The stent grafts are constructed of woven polyester fabric sewn
to self-expanding nitinol stents with braided polyester and monofilament
polypropylene suture. (Fig. 1) Both components are fully stented to provide
stability and the expansile force necessary to open the lumen of the graft
during deployment. Additionally, the nitinol stents provide the necessary
attachment and seal of the graft to the vessel wall.
To assist with alignment, the proximal component has an uncovered stent. For
added fixation and sealing, the proximal component has an internal sealing
stent with fixation barbs that protrude through the graft material. In addition,
the bare stent at the distal end of the distal component also contains barbs.
On devices with diameters of 40-46 mm, the proximal sealing stent remains
constrained to ensure alignment with the inner curvature of the aorta.
To facilitate fluoroscopic visualization of the stent graft, gold radiopaque
markers are positioned on each end of the proximal and distal components.
Gold markers are placed on stent apices at the proximal and distal aspects
of the graft margins, denoting the edge of the graft material, to assist with
deployment accuracy.

1.2 Introduction System

The Zenith Alpha Thoracic Endovascular Graft is shipped preloaded onto an
introduction system. 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 enables precise positioning
before deployment of the proximal and distal components.
The main body graft components are deployed from a 16 French (6 mm OD),
18 French (7.1 mm OD), or 20 French (7.7 mm OD) introduction system. The
proximal component's introduction system is slightly precurved to assist in
proximal inferior wall apposition of the graft during deployment. (Fig. 2) These
systems use either a single locking mechanism (for the proximal component
and distal extension) or dual locking mechanisms (for the distal component) to
secure the endovascular graft onto the introduction system until the physician
releases it. All introduction systems are compatible with a .035 inch wire guide.
The introduction 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. The Flexor Introducer Sheath resists kinking and is
hydrophilic coated. Both features are intended to enhance trackability in the
iliac arteries and thoracic aorta.

1.3 Zenith Alpha Thoracic Endovascular Graft Ancillary Component

An endovascular ancillary component is available. The Zenith Alpha Thoracic
Endovascular Graft ancillary components are cylindrical components
constructed from the same woven polyester fabric, self-expanding nitinol stents,
and polyester and polypropylene suture used to construct the main body graft
components. At the distal and proximal graft margins, the z-stents are attached
to the inner surface for enhanced sealing. (Fig. 1) Distal extensions can be used
to provide additional length to the endovascular graft distally or to increase the
length of overlap between components. Additional proximal components may
be used to extend graft coverage proximally.
The Zenith Alpha Thoracic Endovascular Graft Distal Extension is deployed
from a 16 French (6 mm OD), 18 French (7.1 mm OD), or 20 French (7.7 mm OD)
introduction system. (Fig. 2) A single locking mechanism secures the
endovascular graft to the introduction system until it is released by the
physician. The locking mechanism is released by turning the blue rotation
handle. All systems are compatible with a .035 inch wire guide.
To facilitate fluoroscopic visualization of the distal extension, gold radiopaque
markers are positioned on the ends of the graft. Gold markers are placed on
stent apices at the proximal and distal aspects of the graft margins, denoting
the edge of the graft material, to assist with deployment accuracy.

2 INDICATIONS FOR USE

The Zenith Alpha Thoracic Endovascular Graft is indicated for the endovascular
treatment of patients with aneurysms or ulcers of the descending thoracic aorta
having vascular morphology suitable for endovascular repair (Fig. 3), including:
• Iliac/femoral anatomy that is suitable for access with the required
introduction systems
• Nonaneurysmal aortic segments (fixation sites) proximal and distal to the
thoracic aneurysm or ulcer:
• with a length of at least 20 mm, and
• with a diameter measured outer-wall-to-outer-wall of no greater than
42 mm and no less than 20 mm

3 CONTRAINDICATIONS

The Zenith Alpha Thoracic Endovascular Graft is contraindicated in:
• Patients with known sensitivities or allergies to polyester, polypropylene,
nitinol, or gold.
• Patients who have a condition that threatens to infect the endovascular
graft.

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 Alpha Thoracic Endovascular Graft should be used only 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 or ulcers, unacceptable decrease
in fixation length (vessel and component overlap) and/or endoleak. An
increase in aneurysm or ulcer size and/or persistent endoleak or migration
may lead to rupture of the aneurysm or ulcer.
• Patients experiencing leaks or reduced blood flow through the graft may
be required to undergo secondary endovascular interventions or surgical
procedures.
• Always have a qualified surgery team 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 Alpha Thoracic Endovascular Graft is designed to treat aortic
neck diameters no smaller than 20 mm and no larger than 42 mm. The
Zenith Alpha Thoracic Endovascular Graft is designed to treat proximal aortic
necks (distal to either the left subclavian or left common carotid artery) of
at least 20 mm in length. Additional proximal aortic neck length may be
gained by covering the left subclavian artery (with or without discretionary
transposition) when necessary to optimize device fixation and maximize
aortic neck length. Graft length should be selected to cover the aneurysm or
ulcer as measured along the greater curve of the aneurysm, plus a minimum
of 20 mm of seal zone on the proximal and distal ends. A distal aortic neck
length of at least 20 mm proximal to the celiac axis is required. These sizing
measurements are critical to the performance of the endovascular repair.
In patients with a large proximal aortic vessel diameter and aneurysms on
the inner curvature, there is a risk that the graft may deploy in an angulated
position if the sealing zone is less than 20 mm.
• Adequate iliac or femoral access is required to introduce the device into
the vasculature. Careful evaluation of vessel size, anatomy, and disease
state is required to ensure successful sheath introduction and subsequent
withdrawal, as vessels that are significantly calcified, occlusive, tortuous, or
thrombus lined may preclude introduction of the endovascular graft and/
or increase the risk of embolization. A vascular conduit technique may be
necessary to achieve access in some patients.
• Key anatomic elements that may affect successful exclusion of the thoracic
aneurysm or ulcer include severe angulation (radius of curvature < 20 mm
and localized angulation > 45 degrees); short proximal or distal fixation
sites (< 20 mm); an inverted funnel shape at the proximal fixation site or
a funnel shape at the distal fixation site (greater than a 10% change in
diameter over 20 mm of fixation site length); and circumferential thrombus
and/or calcification at the arterial fixation sites. Irregular calcification and/
or plaque may compromise the attachment and sealing at the fixation sites.
In the presence of anatomical limitations, a longer neck length may be
required to obtain adequate sealing and fixation. Necks exhibiting these key
anatomic elements may be more conducive to graft migration. In patients
with large aneurysms on the outer curvature close to the left subclavian, it
may be difficult to track the device around the arch, and extra support may
be needed using a brachio-femoral wire. If difficulty is noted in tracking the
second component through tortuous anatomy of the thoracic aorta, extra
support may be provided using a brachio-femoral wire.
• The safety and effectiveness of the Zenith Alpha Thoracic Endovascular Graft
and ancillary components have not been evaluated in the following patient
populations:
• aortobronchial and aortoesophageal fistulas
• aortitis or inflammatory aneurysms
• diagnosed or suspected genetic connective tissue disease (e.g., Marfans or
Ehlers-Danlos Syndrome)
• dissections
• females who are pregnant, breastfeeding, or planning to become
pregnant within 60 months
• leaking, pending rupture or ruptured aneurysm
• patients less than 18 years of age
• mycotic aneurysms
• pseudoaneurysms resulting from previous graft placement
• systemic infection (e.g., sepsis)
• access vessels that preclude safe insertion
• inability to preserve the left common carotid artery and celiac artery
• previous repair in descending thoracic aorta
• surgical or endovascular AAA repair within 30 days before or after TAA
repair
• bleeding diathesis, uncorrectable coagulopathy, or refuses blood
transfusion
• stroke within 3 months
• untreatable reaction to contrast, which cannot be adequately
premedicated
• Successful patient selection requires specific imaging and accurate
measurements; please see Section 4.3, Pre-Procedure Measurement
Techniques and Imaging.
• If occlusion of the left subclavian artery ostium is required to obtain
adequate neck length for fixation and sealing, transposition or bypass of the
left subclavian artery may be warranted.
• Risk of in-graft thrombus has been observed when the Zenith Alpha
Endovascular Graft has been used to treat blunt thoracic aortic injuries.
• The Zenith Alpha Thoracic Endovascular Graft is not recommended for
patients who cannot tolerate contrast agents necessary for intraoperative
and postoperative follow-up imaging, or who are unable to undergo, or
will not be compliant with, the necessary preoperative and postoperative
imaging and implantation studies as described in Section 11, IMAGING
GUIDELINES AND POSTOPERATIVE FOLLOW-UP. All patients should be
monitored closely and checked periodically for change in the condition of
their disease and the integrity of the endoprosthesis.
• The Zenith Alpha Thoracic Endovascular Graft is not recommended for
patients whose weight and/or size would compromise or prevent the
necessary imaging requirements.
• Graft implantation may increase the risk of paraplegia or paraparesis where
graft exclusion covers the origins of dominant spinal cord or intercostal
arteries.
• 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 ulcers, 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 POSTOPERATIVE FOLLOW-UP.
• The long-term performance of endovascular grafts has not yet been
established in young patients and patients performing extreme sports.
• After endovascular graft placement, patients should be regularly monitored
for endoleak flow, thoracic aneurysm or ulcer growth, or changes in the
structure or position of the endovascular graft.

4.3 Pre-Procedure Measurement Techniques and Imaging

• All lengths and diameters of the devices necessary to complete the
procedure should be available to the physician, especially when
preoperative case planning measurements (treatment diameters/lengths)
are not certain. This approach allows for greater intraoperative flexibility to
achieve optimal procedural outcomes.
• Lack of non-contrast CT imaging may result in failure to appreciate iliac or
aortic calcification that may preclude access or reliable device fixation and
seal.
• Pre-procedure imaging reconstruction thicknesses > 3 mm may result
in suboptimal device sizing, or in failure to appreciate focal stenoses from CT.
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