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ENGLISH
ZENITH FLEX® 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 surgical consequences or injury
to the patient.
CAUTION: Federal (U.S.A.) law restricts this device to sale by or on the
order of a physician.
CAUTION: All contents of the outer pouch (including the introduction
system and the endovascular grafts) are supplied sterile, for single use
only.
For the Zenith product line there are four applicable Suggested Instructions
for Use (IFU). This IFU describes the Suggested Instructions for Use for the
Zenith Flex AAA Endovascular Graft (main body and iliac legs). For information
on other Zenith components, please refer to the following Suggested
Instructions for Use:
• Zenith AAA Endovascular Graft (Zenith AAA Endovascular Graft main body
and iliac legs);
• Zenith AAA Endovascular Graft Ancillary Components (main body
extension, iliac leg extension, converter and iliac plug);
• Zenith®
Renu™ AAA Ancillary Graft (main body extension and converter
configurations); and
• CODA® Balloon Catheter.
1 DEVICE DESCRIPTION
1.1 Aortic Main Body and Iliac Leg Components
The Zenith Flex AAA 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 full-thickness woven polyester fabric
sewn to self-expanding stainless steel Cook-Z® stents with braided polyester
and monofilament 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.
The bare suprarenal stent at the proximal end of the graft contains barbs
that are placed at 3 mm increments for additional fixation of the device. To
facilitate fluoroscopic visualization of the stent graft, gold radiopaque markers
are positioned as follows: one on the lateral aspect of the most distal stent on
the contralateral limb of the bifurcated section of the main body and four in
a circumferential orientation within 2 mm of the most superior aspect of the
graft material.
1.2 Main Body Delivery System
The Zenith Flex AAA Endovascular Graft main body is shipped preloaded
onto the H&L-B One-Shot 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 H&L-B
One-Shot 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 delivery system uses an 18, 20 or 22 French H&L-B One-
Shot Introduction System. Dual trigger-wire release mechanisms lock the
endovascular graft onto the delivery system until released by the physician. 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. The main body delivery systems feature 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 Iliac Leg Delivery System
The Zenith AAA Endovascular Graft iliac legs are shipped preloaded onto the
H&L-B One-Shot Introduction System. (Fig. 3) The delivery system is designed
for ease of use with minimal preparation. The iliac leg delivery system uses
a 14 or 16 French H&L-B One-Shot Introduction System. All systems are
compatible with a .035 inch wire guide.
1.4 Zenith AAA Endovascular Graft Ancillary Components
Additional ancillary endovascular components (main body extensions, iliac
leg extensions, converters and iliac plugs) are available. (Fig. 4) Refer to the
Zenith AAA Endovascular Graft Ancillary Components Instructions for Use for
more information.
2 INDICATIONS FOR USE
The Zenith Flex AAA Endovascular Graft with the H&L-B One-Shot Introduction
System is indicated for the endovascular treatment of patients with abdominal
aortic or aorto-iliac aneurysms having morphology suitable for endovascular
repair, including:
• Adequate iliac/femoral access compatible with the required introduction
systems,
• 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 7.5-20 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
• 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 Flex AAA Endovascular Graft with the H&L-B One-Shot
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
10.1, Physician Training.
• Additional endovascular interventions or conversion to standard open
surgical repair following initial endovascular repair should be considered for
patients experiencing an enlarging aneurysm, 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.
4.2 Patient Selection, Treatment and Follow-Up
• The Zenith Flex AAA Endovascular Graft is designed to treat aortic neck
diameters no smaller than 18 mm and no larger than 32 mm. The Zenith
Flex AAA Endovascular Graft is designed to treat proximal aortic necks
(distal to the lowest renal artery) of at least 15 mm in length. Iliac artery
distal fixation site greater than 10 mm in length and 7.5 - 20 mm in diameter
(measured outer wall to outer wall) is required. These sizing measurements
are critical to the performance of the endovascular repair.
• Key anatomical elements that may affect successful exclusion of the
aneurysm include severe proximal neck angulation (>60 degrees for
infrarenal neck to axis of AAA or >45 degrees for suprarenal neck relative to
the immediate infrarenal neck); short proximal aortic neck (<15 mm); an
inverted funnel shape (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. In the presence of anatomical
limitations, a longer neck may be required to obtain adequate sealing and
fixation. Irregular calcification and/or plaque may compromise the
attachment and sealing at the fixation sites. Necks exhibiting these key
anatomical elements may be more conducive to graft migration or
endoleak.
• Adequate iliac or femoral access is required to introduce the device into the
vasculature. 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 a 16 French to 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
embolization. A vascular conduit technique may be necessary to achieve
success in some patients.
• The Zenith Flex AAA Endovascular Graft with the H&L-B One-Shot
Introduction System is not recommended in patients who cannot tolerate
contrast agents necessary for intraoperative and postoperative follow-up
imaging. All patients should be monitored closely and checked periodically
for a change in the condition of their disease and the integrity of the
endoprosthesis.
• The Zenith Flex AAA Endovascular Graft with the H&L-B One-Shot
Introduction System is not recommended in patients exceeding weight
and/or size limits which compromise or prevent the necessary imaging
requirements.
• 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.
• Multiple large, patent lumbar arteries, mural thrombus and a patent inferior
mesenteric artery may all predispose a patient to Type II endoleaks. Patients
with uncorrectable coagulopathy may also have an increased risk of Type II
endoleak or bleeding complications.
• The safety and effectiveness of the Zenith Flex AAA Endovascular Graft with
the H&L-B One-Shot Introduction System 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 mesenteric artery
• genetic connective tissue disease (e.g., Marfans or Ehlers-Danlos
Syndromes)
• concomitant thoracic aortic or thoracoabdominal aneurysms
• patients with active systemic infections
• pregnant or nursing females
• morbidly obese patients
• less than 18 years of age
• patients with less than 15 mm in length or greater than 60 degrees
angulation of the proximal aortic neck relative to the long axis of the
aneurysm.
• Successful patient selection requires specific imaging and accurate
measurements; please see Section 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 pre-
operative case planning measurements (treatment diameters/lengths) are
not certain. This approach allows for greater intraoperative flexibility to
achieve optimal procedural outcomes.
4.3 Pre-Procedure Measurement Techniques and Imaging
• 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 stenoses from CT.
• Clinical experience indicates that contrast-enhanced spiral computed
tomographic angiography (CTA) with 3-D reconstruction is the strongly
recommended imaging modality to accurately assess patient anatomy prior
to treatment with the Zenith Flex AAA Endovascular Graft. If contrast-
enhanced spiral CTA with 3-D reconstruction is not available, the patient
should be referred to a facility with these capabilities.
• Clinicians recommend positioning the x-ray C-arm during procedural
angiography such that the origins of the renal arteries, and particularly the
lowest patent renal artery, are well demonstrated prior to deployment of
the proximal edge of the graft material (sealing stent) of the main body.
Additionally, angiography should demonstrate the iliac artery bifurcations
such that the distal common iliacs are well defined relative to the origin of
the internal iliac arteries bilaterally, prior to deployment of the iliac leg
components.
Diameters:
Utilizing CT, diameter measurements should be determined from the outer
wall to outer wall vessel diameter (not lumen measurement) to help with
proper device sizing and device selection. The contrast-enhanced spiral CT
scan must start 1 cm superior to the celiac axis and continue through the
femoral heads at an axial thickness slice of 3 mm or less.
Lengths:
Utilizing CT, length measurements should be determined to accurately
assess infrarenal proximal neck length as well as planning main body sizes
and leg components for the Zenith Flex AAA Endovascular Graft. These
reconstructions should be performed in sagittal, coronal, and 3-D.
• 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 aneurysm or changes in the
structure or position of the endovascular graft) should receive enhanced
follow-up. Specific follow-up guidelines are described in Section 12,
IMAGING GUIDELINES AND POSTOPERATIVE FOLLOW-UP.
