Device Description; Zenith Branch Endovascular Graft-Iliac Bifurcation; Zenith Branch Endovascular Graft-Iliac Bifurcation Delivery System; Additional Components - COOK Medical Zenith Branch Gebrauchsanweisung

ENGLISH
ZENITH® BRANCH ENDOVASCULAR GRAFT-ILIAC BIFURCATION
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.
For information on other Zenith components, please refer to the
appropriate Instructions for Use.

1 DEVICE DESCRIPTION

1.1 Zenith Branch Endovascular Graft-Iliac Bifurcation

The Zenith Branch Endovascular Graft-Iliac Bifurcation is a bifurcated
branch vessel graft with openings to connect the common iliac, sidebranch,
and external iliac segments. (Figure 1)
The graft is constructed of full-thickness woven polyester fabric sewn to
self-expanding stainless steel and nitinol Cook Z
polyester and mono lament polypropylene suture. The graft is fully stented
to provide stability and the expansile force necessary to open the lumen of
the graft during deployment. Nitinol rings positioned at the proximal end
of the graft and within the sidebranch help maintain lumen patency during
access. Additionally, the Cook Z-stents provide the necessary seal of the
graft to the vessel wall.
To facilitate uoroscopic visualization of the stent graft, four radiopaque
gold markers are positioned along the internal iliac side of the proximal
portion of the graft to indicate the position of the sidebranch segment.
Additional components such as Zenith Iliac Leg grafts (e.g., TFLE, ZSLE) and
balloon-expandable covered peripheral stents are required. Each individual
device has its own separate delivery system. Please refer to the relevant
Instructions for Use.

1.2 Zenith Branch Endovascular Graft-Iliac Bifurcation Delivery System

The Zenith Branch Endovascular Graft-Iliac Bifurcation is shipped pre-loaded
onto the H&L-B One-Shot Introduction System. (Figure 2) It has a sequential
deployment method with built-in features to provide continuous control of
the endovascular graft throughout the deployment procedure.
The proximal end of the graft is attached to the delivery system by two
nitinol trigger wires. The distal end of the graft is also attached to the
delivery system and held by an independent stainless steel trigger-wire. The
H&L-B One-Shot Introduction System enables precise positioning and allows
readjustment of the nal graft position before full deployment. The delivery
system uses a 20 French (6.7 mm I.D.) H&L-B One-Shot Introduction System
that includes both a pre-loaded catheter, used to facilitate cannulation
of the side branch, and wire guide, used to ensure that the lumen of
the catheter is preserved during loading and shipping. All systems are
compatible with a 0.035 inch (0.89 mm) wire guide. For added hemostasis,
the Captor Hemostatic Valve can be opened or closed for the introduction
and/or the removal of ancillary devices into and out of the sheath.
The Zenith Branch Endovascular Graft-Iliac Bifurcation 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. In addition, the pre-loaded catheter is curved in order to
enhance the positioning capability of the wire guide during the snaring process.

1.3 Additional Components

Additional components (iliac leg graft, balloon-expandable covered
peripheral stent) are also required.
Zenith Iliac Leg grafts are available (e.g. TFLE, ZSLE) and are constructed
from the same materials used in the construction of the Zenith Branch
Endovascular Graft-Iliac Bifurcation. Some sizing and ordering details
on the Zenith AAA Endovascular Iliac Leg Graft shipped preloaded on
the H&L-B One-Shot Introduction System (TFLE) can be found in these
Instructions for Use. For all of the Zenith iliac leg grafts and delivery
systems, refer to the respective Instructions for Use for deployment
instructions. The common iliac section of the Zenith Branch Endovascular
Graft-Iliac Bifurcation, positioned in the common iliac artery, will be
connected to the short (contralateral) limb of a Zenith bifurcated graft (e.g.
Zenith AAA Endovascular Graft) by a standard iliac leg of suitable length
and with a distal diameter of 16 mm (e.g. TFLE-16-XX, ZSLE-16-XX-ZT).
A balloon-expandable covered peripheral stent will be deployed within the
sidebranch segment and will extend into the internal iliac artery. Refer to
the Instructions for Use of this device for deployment instructions.

2 INDICATIONS FOR USE

The Zenith Branch Endovascular Graft-Iliac Bifurcation with the H&L-B
One-Shot Introduction System is indicated for the endovascular treatment
of patients with an aortoiliac or iliac aneurysm, an insu cient distal sealing
site within the common iliac artery, and having morphology suitable for
endovascular repair, including:
introduction system,
11 mm and no less than 8 mm.

3 CONTRAINDICATIONS

There are no known contraindications for these devices.

4 WARNINGS AND PRECAUTIONS

4.1 General

warnings and precautions may lead to serious consequences or injury to
the patient.
Shot Introduction System should only be used by physicians and teams
trained in vascular interventional techniques and in the use of this device.
aortic calcification, which may preclude access or reliable device fixation
and seal.
optimal device sizing, or in failure to appreciate focal stenoses from CT.
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 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 Post-Operative Follow-Up.
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 or stent fracture) 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.
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.
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
®
-stents with braided
and/or persistent endoleak may lead to aneurysm rupture.
leaks may be required to undergo secondary interventions or surgical
procedures.
reintervention procedures in the event that conversion to open surgical
repair is necessary.
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

morphology (minimal tortuosity, occlusive disease, and/or calcification)
should be compatible with vascular access techniques and delivery
systems of the profile of a 20 French (7.7 mm O.D.) 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.
aneurysm include tortuosity of any or all of the vessels involved,
undersized or oversized iliac arteries, circumferential thrombus,
aneurysm of the internal and/or external iliac artery and/or calcification
of the arterial implantation sites. Irregular calcification and/or plaque may
compromise the fixation and sealing of the implantation sites and the
ability to advance the introducer systems.
One-Shot Introduction System is not recommended in patients who
cannot tolerate contrast agents necessary for intra-operative and post-
operative follow-up imaging.
One-Shot Introduction System is not recommended in patients
exceeding weight and/or size limits, which compromise or prevent the
necessary imaging requirements.
One-Shot Introduction System is not recommended in patients with
known sensitivities or allergies to stainless steel, polyester, nitinol (nickel,
titanium), solder (tin, silver), polypropylene or gold.
endovascular graft infection.
increase the risk of pelvic/bowel ischemia.

4.3 Implant Procedure

procedure based on hospital and physician preferred protocol. If heparin
is contraindicated, an alternative anticoagulation should be considered.
and insertion to decrease the risk of endoprosthesis contamination and
infection.
sheath, the surface must be wiped with 4x4 gauze pads soaked in saline
solution. Always keep the sheath hydrated for optimal performance.
delivery system and the Zenith Branch Endovascular Graft-Iliac Bifurcation.
confirm proper operation of the delivery system components, proper
placement of the graft, and desired procedural outcome.
H&L-B One-Shot Introduction System requires administration of
intravascular contrast. Patients with pre-existing renal insufficiency may
have an increased risk of renal failure post-operatively. Care should be
taken to limit the amount of contrast media used during the procedure.
delivery system, be careful to rotate all of the components of the system
together (from outer sheath to inner cannula).
Endovascular Graft-Iliac Bifurcation within the vessel or with additional
components may result in increased risk of endoleak, migration or
inadvertent occlusion of internal iliac artery.
Bifurcation may result in increased risk of migration. Incorrect deployment
or migration of the endoprosthesis may require surgical intervention.
resistance is felt during advancement of the wire guide or delivery
system. Stop and assess the cause of resistance. Vessel or catheter
damage may occur. Exercise particular care in areas of stenosis,
intravascular thrombosis or in calcified or tortuous vessels.
aneurysm. Significant disturbances may dislodge fragments of thrombus
which can cause distal embolization.
diameter to seal with both the sidebranch segment and the internal iliac
artery, and of sufficient length to overlap 10-14 mm with the sidebranch
segment and 10 mm (with 20-30 mm being preferred) with the distal
fixation site in the internal iliac artery.
its position in the event reinstrumentation of the graft is necessary.

Molding Balloon Use

closed to accommodate the insertion and subsequent withdrawal of a
molding balloon.
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