Main Body Distal (Bottom) Deployment; Ipsilateral Iliac Leg Placement And Deployment; Molding Balloon Insertion; Final Angiogram - COOK Medical Zenith Alpha Mode D'emploi

6 . Check the graft position and reposition if necessary .
7 . Continue to deploy the graft by withdrawing the sheath while
continuously checking the position of the graft .
8 . Stop withdrawing the sheath as soon as the distal end of the contralateral
iliac leg graft is released .
9 . Under fluoroscopy and after verification of iliac leg graft position, loosen
the pin vise and retract the inner cannula to dock the tapered dilator
to the positioner . Tighten the pin vise . Maintain sheath position while
withdrawing the gray positioner with secured inner cannula . (Fig . 17)
10 . Re-check the position of the wire guide .

10.1.7 Main Body Distal (Bottom) Deployment

1 . Return to the ipsilateral side .
2 . Fully deploy the ipsilateral limb of the main body by withdrawing
the sheath until the most distal stent has expanded . (Fig . 18) Stop
withdrawing the sheath .
NOTE: The distal stent is still secured to the delivery system .
3 . While holding the black gripper, turn the gray safety lock knob
counterclockwise to engage the blue rotation handle . (Fig . 19)
NOTE: If you are unable to release the gray safety lock knob, ensure that the
safety lock knobs are aligned and that the handle has not been over-rotated
(i .e ., rotated more than two full rotations from its original position) . The user
should then release the gray safety lock knob by hand . If unable to do this
by hand, use gauze or forceps to forcefully turn the safety lock knob .
4 . To release the wire securing the ipsilateral limb to the delivery system,
turn the blue rotation handle in the direction of the arrow (clockwise)
until a stop is felt . (Fig . 20)
NOTE: Handle system mechanism may be manually overridden; however,
do not attempt any troubleshooting actions before referring to Section 12,
MAIN BODY RELEASE TROUBLESHOOTING .
NOTE: Turning the rotation handle releases the distal stent of the main
body graft . If the distal stent does not release, see Section 12, MAIN BODY
RELEASE TROUBLESHOOTING .
5 . Withdraw the entire inner subassembly through the sheath by holding
the Captor Hemostatic Valve stationary and pulling on the black gripper .
Confirm that the Captor sleeve is removed along with the inner sub
assembly . (Fig . 21)
NOTE: Maintain position of sheath and wire guide .
6 . Close the Captor Hemostatic Valve on the introducer sheath by turning it
in a clockwise direction until it stops . (Fig . 22)

10.1.8 Ipsilateral Iliac Leg Placement and Deployment

NOTE: If using this device in conjunction with the Zenith Spiral-Z AAA
Iliac Leg, refer to the Zenith Spiral-Z AAA Iliac Leg IFU for appropriate
deployment and overlap instructions .
NOTE: Ensure the Captor Hemostatic Valve on the main body introducer
sheath is turned to the open position . (Fig . 23)
1 . Position the image intensifier to show both the ipsilateral internal iliac
artery and ipsilateral common iliac artery .
2 . Prior to the introduction of the ipsilateral iliac leg delivery system, inject
contrast through the main body femoral sheath to locate the ipsilateral
internal iliac artery .
3 . Utilize the main body graft wire and sheath assembly to introduce the
ipsilateral iliac leg graft . Advance the 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 .
4 . Continue advancing slowly until the proximal edge of the ipsilateral leg
graft aligns with the proximal edge of the previously-placed contralateral
leg graft . (Figs . 24 and 25)
5 . Confirm position of the distal end of the iliac leg graft . Using the distal
gold marker as a reference point, reposition the iliac leg graft if necessary
to ensure internal iliac patency .
6 . To deploy, hold the iliac leg graft in position with the gray positioner
while withdrawing the sheath approximately 10 mm . (Fig . 26)
7 . Check the graft position and reposition if necessary .
8 . Continue to deploy the graft by withdrawing the sheath while
continuously checking the position of the graft . (Fig . 27)
9 . Under fluoroscopy and after verification of iliac leg graft position, loosen
the pin vise, and retract the inner cannula to dock the tapered dilator
to the positioner . Tighten the pin vise . Maintain sheath position while
withdrawing the positioner with secured inner cannula . (Fig . 28)
10 . Close the Captor Hemostatic Valve by turning it in a clockwise direction
until it stops .
11 . Re-check the position of the wire guides . Leave the sheath and wire
guides in place .

10.1.9 Molding Balloon Insertion

1 . Prepare the molding balloon as follows:
• Flush the wire lumen with heparinized saline .
• Remove all air from the balloon .
2 . In preparation of the insertion of the molding balloon, open the Captor
Hemostatic Valve by turning counterclockwise .
3 . Advance the molding balloon over the wire guide and through the
hemostatic valve of the main body introduction system to the level of
the renal arteries . Maintain proper sheath positioning .
4 . Tighten the Captor Hemostatic Valve around the molding balloon with
gentle pressure by turning it clockwise .
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 . 29)
CAUTION: Confirm complete deflation of the balloon prior to
repositioning .
CAUTION: The Captor Hemostatic Valve must be open prior to
repositioning of the molding balloon .
6 . Withdraw the molding balloon to the ipsilateral limb overlap region and
expand .
CAUTION: The 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 .
8 . Deflate and remove the molding balloon . Transfer the molding balloon
onto the contralateral wire guide and into the contralateral iliac leg
introduction system . Advance the molding balloon to the contralateral
limb overlap and expand .
CAUTION: Confirm complete deflation of the balloon prior to
repositioning .
9 . Withdraw the molding balloon to the contralateral iliac leg/vessel distal
fixation site and expand . (Fig . 29)
CAUTION: Do not inflate the balloon in the vessel outside of the graft .
10 . Remove the molding balloon and replace it with an angiographic
catheter to perform completion angiograms .
11 . Remove or replace all stiff wire guides to allow the iliac arteries to
resume their natural position .

Final Angiogram

1 . Position an angiographic catheter just above the level of the renal
arteries . Perform angiography to verify that the renal arteries are patent
and that there are no endoleaks . Verify patency of the internal iliac
arteries .
2 . Confirm there are no endoleaks or kinks and verify position of the
proximal gold radiopaque markers . Remove the sheaths, wires and
catheters .
NOTE: If endoleaks or other problems are observed, refer to Section 10 .2,
Zenith Low Profile AAA/Zenith Alpha Abdominal Ancillary Components .
3 . Repair vessels and close in standard surgical fashion .
10.2 Zenith Low Profile AAA/Zenith Alpha Abdominal Ancillary
Components

General Use Information

Inaccuracies in device size selection or placement, changes or anomalies
in patient anatomy or procedural complications can require placement of
additional endovascular grafts, extensions and converters . Regardless of
the device placed, the basic procedure(s) will be similar to the maneuvers
required and described previously in this document . It is vital to maintain
wire guide access .
Standard techniques for placement of arterial access sheaths, guiding
catheters, angiographic catheters and wire guides should be employed
during use of the Zenith Low Profile AAA/Zenith Alpha Abdominal
ancillary components . Low Profile AAA/Zenith Alpha Abdominal ancillary
components are compatible with .035 inch wire guides .
Zenith Low Profile AAA/Zenith Alpha Abdominal ancillary components are
compatible with the Zenith Low Profile AAA Endovascular Graft as well as
the Zenith Alpha Abdominal Endovascular Graft .

10.2.1 Converter

Converters can be used to convert a bifurcated graft into an aortouni-
iliac graft, if necessary (e .g ., cases of Type III endoleak, limb occlusion or
unattainable contralateral limb cannulation) . (Fig . 30)
Converter Preparation/Flush
1 . Remove the inner stylet (from the inner cannula), cannula protector
(from the inner cannula) and dilator tip protector (from the dilator tip) .
Remove the Peel-Away sheath from the back of the hemostatic valve .
(Fig . 31) Elevate the distal tip of the 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 . 32) Continue to inject
a full 20 cc of flushing solution through the device . Discontinue injection
and close stopcock .
NOTE: Graft flushing solution of heparinized saline is often used .
2 . Attach a syringe with heparinized saline to the hub of the inner cannula .
Flush until fluid exits the dilator tip . (Fig . 33)
NOTE: When flushing the system, elevate the distal end of the system to
facilitate removal of air .
3 . Soak sterile gauze pads in saline solution and use them to wipe the
Flexor introducer sheath to activate the hydrophilic coating . Hydrate
both the sheath and the dilator liberally .
Converter Placement and Deployment
1 . Remove the main body delivery sheath . Use the main body graft wire
guide to introduce the converter into the main body .
NOTE: The converter delivery system cannot be introduced through the
main body or iliac leg introducer sheath .
2 . Advance slowly until the converter is at the site of the required
intervention . (Fig . 34) Verify appropriate stent graft overlap to ensure
proper sealing and resistance to migration . The proximal two stents
should be positioned in the main body graft and the distal two stents
should be positioned in the ipsilateral leg .
3 . Deploy the device by withdrawing the sheath while stabilizing the gray
positioner of the delivery system . (Figs . 35 and 36)
4 . Remove the safety lock from the black trigger-wire release mechanism .
Withdraw and remove the trigger-wire by sliding the black trigger-wire
release mechanism off the handle, and then remove via the slot over the
inner cannula . (Fig . 37)
5 . Continue to deploy the device until the distal stent is uncovered .
6 . Withdraw the tapered tip of the introducer back through the converter
graft and delivery system while maintaining wire guide position . Ensure
the endovascular graft is not displaced during the withdrawal of the
delivery system .
7 . Close the Captor Hemostatic Valve by turning it in a clockwise direction
until it stops . (Fig . 38)
Converter Molding Balloon Insertion
NOTE: For information on the use of recommended products, refer to the
individual product's Instructions for Use .
1 . Prepare the molding balloon as follows:
• Flush the wire lumen with heparinized saline .
• Remove all air from the balloon .
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