Device Description; Zenith Aaa Ancillary Components; Main Body Extension Delivery System; Iliac Leg Delivery System - COOK Medical Zenith Instrucciones De Uso

ENGLISH
ZENITH® AAA ANCILLARY COMPONENTS WITH Z-TRAK™
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 five applicable Suggested Instructions
for Use (IFU) . This IFU describes the Suggested Instructions for Use for the
Zenith AAA Endovascular Graft Ancillary Components (main body extension,
iliac leg, iliac leg extension, converter and iliac plug) . 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,
iliac legs, iliac leg extension, main body extension, converter and occluder);
• Zenith Flex® AAA Endovascular Graft (Zenith Flex AAA Endovascular Graft
main body and iliac legs);
• Zenith Renu® AAA Ancillary Graft (main body extension and converter
configurations);
• Coda® Balloon Catheter; and
• Zenith® Spiral-Z™ AAA Iliac Leg

1 DEVICE DESCRIPTION

1.1 Zenith AAA Ancillary Components

Zenith AAA Ancillary Components include main body extensions, iliac legs,
iliac leg extensions, converters and iliac plugs . (Fig. 1) These components are
constructed from the same materials as the principal graft modules . All
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 aortic main body
extensions, iliac legs and iliac leg extensions can be used to provide
additional length to their respective portions of the endovascular graft . The
converters and iliac plugs can be used to convert a bifurcated graft into an
aorto-uniiliac graft, if necessary (e .g ., cases of Type III endoleak, limb occlusion
or unattainable contralateral limb cannulation) .
All Zenith AAA Endovascular Graft Ancillary Components feature a Flexor
Introducer Sheath which resists kinking and is hydrophilically coated . 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 . Both features are intended to enhance trackability in the iliac arteries
and abdominal aorta .

1.2 Main Body Extension Delivery System

Main body extensions utilize 18 and 20 French Z-Trak Introduction Systems .
(Fig. 2) The main body extension introduction system contains a single
trigger-wire release mechanism . The trigger wires secure the endovascular
graft onto the delivery system until released by the physician . Unlike the
Zenith AAA main body delivery system, no top cap is included with the dilator
tip because the main body extension component does not contain a barbed,
uncovered suprarenal stent . Deployment of the main body extension is
achieved by sheath retraction and trigger-wire removal .

1.3 Iliac Leg Delivery System

The Zenith AAA iliac legs are shipped preloaded onto the Z-Trak 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 Z-Trak
Introduction System . All systems are compatible with a .035 inch wire guide .
Deployment is achieved by sheath retraction .

1.4 Iliac Leg Extension Delivery System

Iliac leg extensions are deployed using 14 and 16 French Z-Trak Introduction
Systems similar to those used to deploy the Zenith AAA iliac legs . (Fig. 4)
These delivery systems have no trigger-wire release mechanism or top cap
assembly . Deployment is achieved by sheath retraction .

1.5 Converter Delivery System

Converters utilize 18 and 20 French Z-Trak Introduction Systems . (Fig. 5) The
converter introduction system has no trigger-wire release mechanism or top
cap assembly . Deployment of the converter is achieved by sheath retraction .

1.6 Iliac Plug Delivery System

Iliac plugs are preloaded into 14 and 16 French Z-Trak Introduction Systems .
(Fig. 6) The iliac plug delivery system contains a single trigger-wire release
mechanism . Deployment of the iliac plug is achieved by sheath retraction and
trigger-wire removal .

2 INDICATIONS FOR USE

The Zenith AAA Ancillary Components with the Z-Trak Introduction System
are indicated for use with the Zenith AAA graft during either a primary or a
secondary procedure in patients who have adequate iliac/femoral access
compatible with the required introduction systems .

3 CONTRAINDICATIONS

The Zenith AAA Ancillary Components are contraindicated in:
• Patients with known sensitivities or allergies to stainless steel, polyester,
solder (tin, silver), nitinol, polypropylene 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 AAA Ancillary Components with the Z-Trak Introduction System
should only be used by physicians and teams trained in vascular
interventional techniques (catheter-based and surgical) and in the use of
these devices . Specific training expectations are described in Section 10.1,
Physician Training.
• Additional endovascular interventions or conversion to standard open
surgical repair following 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 .
• The Zenith AAA Ancillary Components have not been evaluated for use with
grafts other than Zenith AAA stent grafts .

4.2 Patient Selection, Treatment and Follow-Up

• The Zenith AAA main body extension is designed to treat aortic neck
diameters no smaller than 18 mm and no larger than 32 mm . The Zenith
AAA main body extension 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 .
• Adequate iliac or femoral access is required to introduce the device into the
vasculature .
• 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); short distal fixation site (<10 mm); 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 fixation and sealing of the implantation sites . Necks
exhibiting these key anatomic elements may be more conducive to graft
migration .
• 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 14 French to 20 French vascular introducer sheath . Vessels that
are significantly calcified, occlusive, tortuous or thrombus-lined may
preclude placement of the ancillary components and/or may increase the
risk of embolization . A vascular conduit technique may be necessary to
achieve success in some patients .
• Size of the pre-existing Zenith AAA Endovascular Graft should be assessed
before selecting a main body extension .
• Use of a 58 mm length main body extension should only be considered
when the length from the lowest renal artery to the bifurcation of the pre-
existing graft is >65 mm for TFB (Zenith AAA Endovascular Graft) main
body grafts and >73 mm for TFFB (Zenith Flex AAA Endovascular Graft)
main body grafts . Failure to use the device in this manner may result in
increased risk of inadvertent occlusion of renal arteries .
• Use of 73 mm length main body extension should only be considered
when the length from the lowest renal artery to the bifurcation of the pre-
existing graft is >86 mm for TFFB (Zenith Flex AAA Endovascular Graft)
main body grafts . Failure to use the device in this manner may result in
increased risk of inadvertent occlusion of renal arteries .
• The Zenith AAA Ancillary Components with the Z-Trak Introduction System
are 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 AAA Ancillary Components with the Z-Trak Introduction System
are 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 AAA Ancillary Components with
the Z-Trak Introduction System have 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
• active systemic infections
• pregnant or nursing females
• morbidly obese patients
• less than 18 years of age
• 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 AAA Ancillary Components . 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
extension . 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 or iliac leg extensions .

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, iliac legs
and ancillary 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.
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