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11 DIRECTIONS FOR USE
Anatomical Requirements
• Iliofemoral access vessel size and morphology (minimal thrombus,
calcium and/or tortuosity) should be compatible with vascular access
techniques and accessories . Arterial conduit techniques may be required .
• For additional anatomical requirements, please refer to the appropriate
main body or Renu IFU from the Zenith AAA Endovascular Graft family of
products . A copy is available online at www .cookmedical .com .
Prior to use of the Zenith Spiral-Z AAA Iliac Leg with the Z-Trak Introduction
System, review this Suggested Instructions for Use booklet . The following
instructions embody a basic guideline for device placement . Variations in the
following procedures may be necessary . These instructions are intended to
help guide the physician and do not take the place of physician judgment .
general Use Information
• Standard techniques for placement of arterial access sheaths, guiding
catheters, angiographic catheters and wire guides should be employed
during use of the Zenith Spiral-Z AAA Iliac Leg with the Z-Trak
Introduction System . The Zenith Spiral-Z AAA Iliac Leg with the Z-Trak
Introduction System is compatible with .035 inch diameter wire guides .
• Endovascular stent grafting is a surgical procedure, and blood loss from
various causes may occur, infrequently requiring intervention (including
transfusion) to prevent adverse outcomes . It is important to monitor
blood loss from the hemostatic valve throughout the procedure, but is
specifically relevant during and after manipulation of the gray positioner .
After the gray positioner has been removed, if blood loss is excessive,
consider placing an uninflated molding balloon or an introduction system
dilator within the valve, restricting flow .
Pre-Implant Determinants
Verify from pre-implant planning that the correct device has been selected .
Determinants include:
1 . Femoral artery selection for introduction of the delivery system (i .e .,
define respective contralateral and ipsilateral iliac arteries)
2 . Angulation of aortic neck, aneurysm and iliac arteries
3 . Diameters of infrarenal aortic neck and distal iliac arteries
4 . Length from the aortic bifurcation of a previously placed main body or
Renu from the Zenith AAA Endovascular Graft family of products to the
internal iliac arteries/attachment site(s)
5 . Aneurysm(s) extending into the iliac arteries may require special
consideration in selecting a suitable graft/artery interface site
6 . Degree of vascular calcification
Patient Preparation
1 . Refer to institutional protocols relating to anesthesia, anticoagulation
and monitoring of vital signs .
2 . Position patient on imaging table allowing fluoroscopic visualization
from the aortic arch to the femoral bifurcations .
3 . Expose selected common femoral artery using standard surgical
technique .
4 . Establish adequate proximal and distal vascular control of selected
femoral vessel .
11.1 Zenith Spiral-Z AAA Iliac Leg System (Fig 2)
NOTE: For directions on how to place a main body or Renu from the Zenith
AAA Endovascular Graft family of products, refer to the Instructions for Use
included with the main body or Renu device .
11.1.1 Contralateral Iliac Leg Preparation/Flush
1 . If applicable, remove gray-hubbed inner stylet (from the inner cannula)
and dilator tip protector (from the dilator tip) . Remove Peel-Away
sheath from back of the hemostatic valve . (Fig . 3) Elevate distal tip of
system and flush through the stopcock on the hemostatic valve until
fluid emerges from the flushing groove near the tip of the introducer
sheath . (Fig . 4) Continue to inject a full 20 cc of flushing solution
through the device . Discontinue injection and close stopcock on the
connecting tube .
NOTE: Graft flushing solution of heparinized saline is often used .
2 . Attach syringe with heparinized saline to the hub on the distal inner
cannula . Flush until fluid exits the distal dilator tip . (Fig . 5)
NOTE: When flushing system, elevate distal end of system to facilitate
removal of air .
3 . Soak sterile gauze pads in saline solution and use to wipe Flexor
introducer sheath to activate the hydrophilic coating . Hydrate both
sheath and dilator liberally .
11.1.2 Ipsilateral Iliac Leg Preparation/Flush
Follow the instructions in the previous section, Contralateral Iliac Leg
Preparation/Flush, to ensure proper flushing of the ipsilateral iliac leg graft
and activation of the hydrophilic coating .
11.1.3 Vascular Access and Angiography
1 . Puncture the selected common femoral arteries using standard
technique with an 18 or 19 UT gage arterial needle . Upon vessel entry,
insert:
• Wire guides – standard .035 inch diameter, 145 cm long, J tip or
Bentson Wire Guide
• Appropriate size sheaths (e.g., 6 or 8 French)
• Flush catheter (often radiopaque sizing catheters – e.g., Centimeter
Sizing Catheter or straight flush catheter)
2 . Perform angiography to identify level(s) of aortic bifurcation and iliac
bifurcations .
NOTE: If fluoroscope angulation is used with an angulated neck, it may
be necessary to perform angiograms using various projections .
NOTE: Technical assistance from a Cook product specialist may be
obtained by contacting your local Cook representative .
11.1.4 Contralateral Iliac Leg Placement and Deployment
1 . Position the image intensifier to show both the contralateral internal
iliac artery and contralateral common iliac artery .
2 . Prior to the introduction of the contralateral iliac leg delivery system,
inject contrast through the contralateral femoral sheath to locate the
contralateral internal iliac artery .
3 . Introduce the contralateral iliac leg delivery system into the artery .
Advance slowly until the iliac leg graft overlaps at least one stent and
not past the radiopaque marker band positioned 30 mm from the
proximal end of the iliac leg graft inside the contralateral limb of the
main body . (Fig . 6) If there is any tendency for the main body graft to
move during this maneuver, hold it in position by stabilizing the gray
positioner on the ipsilateral side .
NOTE: A radiopaque marker band is positioned 30 mm from the proximal
end of the iliac leg graft to identify the maximum amount of overlap .
NOTE: If difficulty is encountered advancing the iliac leg delivery
system, exchange to a more supportive wire guide . In tortuous vessels
the anatomy may alter significantly with the introduction of the rigid
wires and sheath systems .
4 . Confirm position of distal end of the iliac leg graft . Reposition the
iliac leg graft if necessary to ensure internal iliac patency, a minimum
overlap of one stent, and a maximum overlap of 30 mm within the
main body endovascular graft .
NOTE: Ensure the Captor Hemostatic Valve on the iliac leg introducer
sheath is turned to the open position . (Fig . 7)
5 . To deploy, hold the iliac leg graft in position with the gripper on the
gray positioner while withdrawing the sheath . (Figs . 8 and 9) Ensure
overlap is maintained .
6 . Stop withdrawing the sheath as soon as the distal end of the iliac leg
graft is released .
7 . Under fluoroscopy and after verification of iliac leg graft position,
loosen pin vise and retract inner cannula to dock tapered dilator
to gray positioner . Tighten pin vise . Maintain sheath position while
withdrawing gray positioner with secured inner cannula .
8 . Close the Captor Hemostatic Valve on the iliac leg introducer sheath by
turning it in a clockwise direction until it stops . (Fig . 10)
9 . Re-check the position of the wire guide .
11.1.5 Ipsilateral Iliac Leg Placement and Deployment
NOTE: Ensure the Captor Hemostatic Valve on the main body introducer
sheath is turned to the open position . (Fig . 11)
1 . Utilize the main body graft wire and sheath assembly to introduce the
ipsilateral iliac leg graft . Advance dilator and sheath assembly into the
main body sheath .
NOTE: In tortuous vessels, the position of the internal iliac arteries may
alter significantly with the introduction of the rigid wires and sheath
systems .
2 . Advance slowly until the ipsilateral iliac leg graft overlaps a minimum
of one stent inside the ipsilateral limb of the main body . (Fig . 12)
NOTE: If an overlap of greater than 55 mm is required, it may be
necessary to consider use of a leg extension in the bifurcation area of
the opposite side .
NOTE: For use with Renu converter, ensure iliac leg overlaps a
minimum of one full iliac leg stent (i .e ., proximal stent of iliac leg graft)
inside the Renu converter .
3 . Confirm position of distal end of the iliac leg graft . Reposition the iliac
leg graft if necessary to ensure internal iliac patency .
NOTE: Ensure the Captor Hemostatic Valve on the iliac leg introducer
sheath is turned to the open position . (Fig . 7)
4 . To deploy, stabilize the iliac leg graft with the gripper on the gray
positioner while withdrawing the iliac leg sheath . If necessary,
withdraw the main body sheath . (Figs . 8 and 13)
5 . Under fluoroscopy and after verification of iliac leg graft position,
loosen pin vise, retract inner cannula to dock tapered dilator to gray
positioner . Tighten pin vise . Maintain main body sheath position while
withdrawing the iliac leg sheath and gray positioner with secured inner
cannula .
6 . Close the Captor Hemostatic Valve on the main body introducer sheath
by turning it in a clockwise direction until it stops .
7 . Re-check the position of the wire guides . Leave sheath and wire guide
in place .
11.1.6 Molding Balloon Insertion
1 . Prepare molding balloon as follows:
• Flush wire lumen with heparinized saline.
• Remove all air from balloon.
2 . In preparation for the insertion of the molding balloon, open the
Captor Hemostatic Valve by turning counter-clockwise . (Fig . 11)
3 . Advance the molding balloon over the wire guide and through the
Captor Hemostatic Valve of the main body introduction system to the
level of the renal arteries . Maintain proper sheath position .
4 . Tighten the Captor Hemostatic Valve around the molding balloon with
gentle pressure by turning it clockwise . (Fig . 10)
CAUTION: Do not inflate the balloon in the vessel outside of the
graft .
5 . Expand the molding balloon with diluted contrast media (as directed
by the manufacturer) in the area of the most proximal covered stent
and the infrarenal neck, starting proximally and working in the distal
direction . (Fig . 14)
CAUTION: Confirm complete deflation of balloon prior to
repositioning .
CAUTION: Captor Hemostatic Valve must be open prior to
repositioning of the molding balloon .
6 . Withdraw the molding balloon to the ipsilateral limb overlap and
expand .
CAUTION: Captor Hemostatic Valve must be open prior to
repositioning of the molding balloon .
7 . Withdraw the molding balloon to the ipsilateral distal fixation site and
expand .
CAUTION: Do not inflate the balloon in the vessel outside of the
graft .
CAUTION: Captor Hemostatic Valve must be open prior to
repositioning of the molding balloon .
8 . Deflate and remove molding balloon . Transfer molding balloon
onto the contralateral wire guide and into the contralateral iliac leg
introduction system . Advance molding balloon to the contralateral limb
overlap and expand .
CAUTION: Confirm complete deflation of balloon prior to
repositioning .
CAUTION: Captor Hemostatic Valve must be open prior to
repositioning of the molding balloon .
