Docking Of Top Cap; Fenestration Stent Placement And Deployment; Distal Bifurcated Body Placement; Contralateral Iliac Wire Guide Placement - COOK Medical Zenith Fenestrated AAA Instructions For Use Manual

c. Remove the black trigger-wire release maechanism.
d. Continue with (15) in Section 10.1.5 Proximal Body Placement.
NOTE: If still unable to remove the black trigger-wire release mechanism
from the top cap, see Section 12 Trigger-Wire Release Troubleshooting.
15. Loosen the pin vise. (Figure 22) Control the position of the graft by
stabilizing the grey positioner of the introducer.
CAUTION: Before deployment of suprarenal stent, verify that the
position of the access wire extends just distal to the aortic arch. Ensure
that the dilator tip will not extend beyond the end of the access wire
guide during advancement and, if required, re-position the access wire
guide into the aortic arch to accommodate.
16. Deploy the suprarenal stent by advancing the top cap inner cannula
1 to 2 mm at a time while controlling the position of the proximal body
until the top stent is fully deployed. (Figures 23a and 23b) Advance
the top cap cannula an additional 1 to 2 cm and then retighten the pin
vise to avoid contact with the deployed suprarenal stent.
WARNING: The Zenith Fenestrated AAA Endovascular Graft
incorporates a suprarenal stent with fixation barbs. Exercise extreme
caution when manipulating interventional devices in the region of the
suprarenal stent.
17. Remove the safety lock from the white trigger-wire release mechanism.
Withdraw and remove the trigger-wire to detach the distal end of
the endovascular graft from the delivery system by sliding the white
trigger-wire release mechanism off the handle and then remove via its
slot over the device inner cannula. (Figure 24)
NOTE: Check to make sure that all trigger-wires are removed prior to
withdrawal of the delivery system.

10.1.6 Docking of Top Cap

1. Loosen the pin vise. (Figure 25)
2. Secure sheath and inner cannula to avoid any movement of these
components.
3. Advance the grey positioner over the inner cannula until it docks with
the top cap. (Figures 26a, 26b and 26c)
NOTE: If resistance occurs, slightly rotate grey positioner and continue to
gently advance.
4. Retighten the pin vise and withdraw the entire top cap and grey
positioner through the graft and through the sheath by pulling on the
inner cannula. (Figure 27) Leave the sheath and wire guide in place.
5. Close the Captor Hemostatic Valve by turning it in a clockwise direction
until it stops.

10.1.7 Fenestration Stent Placement and Deployment

General Use Information
In the event that small fenestrations are being utilized, stents may be
placed to secure positive alignment.
Standard techniques for placement of arterial stents should be employed
during use of stents.
1. Return to the guide catheter and wire guide which cannulate the small
fenestration and respective vessel.
2. Introduce appropriately sized balloon expandable stent and advance
to the ostium of the fenestration/vessel. Advance into the vessel,
leaving approximately 5 mm of stent in the aorta. (Figure 28)
NOTE: Fluoroscopic views tangential to the fenestration will optimise
visualisation of the stent position relative to the stent graft.
3. Expand stent.
4. Remove the balloon and replace with an oversized angioplasty
balloon. Advance the balloon until the proximal tip is positioned at the
ostium.
5. Inflate the balloon to flare the intra-aortic segment of the stent. (Figure 29)
CAUTION: This technique requires high quality imaging. Mobile image
intensi ers provide less than adequate imaging quality.
6. Remove the angioplasty balloon.
NOTE: In the event that there is more than one fenestration, repeat the
preceding steps for each additional small fenestration.
7. Withdraw renal access sheaths, catheters and wire guides in the
contralateral side to a level just above the aortic bifurcation.

10.1.8 Distal Bifurcated Body Placement

1. Ensure the delivery system has been flushed with heparnized saline
and that all air is removed from the system.
2. Give systemic heparin and check flushing solutions. Flush after each
catheter and/or wire guide exchange.
3. Before insertion, position distal bifurcated body delivery system on
patient's abdomen under fluoroscopy to determine the orientation of
the contralateral limb. The side arm of the hemostatic valve may serve
as an external reference to the contralateral limb radiopaque marker.
NOTE: Distal bifurcated body delivery system will not pass through the
sheath used to deliver the proximal body.
NOTE: The proximal body delivery sheath must be removed prior to
insertion of the distal bifurcated body delivery system.
4. Insert Distal Bifurcated Body delivery system over the wire, into the
femoral artery with attention to sidearm reference.
CAUTION: Maintain wire guide position during delivery system
insertion.
CAUTION: To avoid any twist in the endovascular graft, during any
rotation of the delivery, be careful to rotate all of the components of
the system together (from outer sheath to inner cannula).
5. Advance delivery system until the contralateral limb is positioned
above and anterior to the origin of the contralateral iliac. (Figure 30)
If the contralateral limb radiopaque marker is not properly aligned,
rotate the entire system until it is correctly positioned half way
between a lateral and an anterior position on the contralateral side.
6. Repeat angiogram to verify:
iliac bifurcation.
Reposition distal bifurcated body as required.
CAUTION: When introducing distal bifurcated body, observe proximal
body closely to avoid any disruption to its position.
NOTE: Ensure the Captor Hemostatic Valve on the Flexor introducer sheath
is turned to the open position. (Figure17)
7. Stabilise the grey positioner (the shaft of the delivery system) while
withdrawing the sheath. Deploy the first two (2) covered stents by
withdrawing the sheath while monitoring device location. Proceed
with deployment until contralateral limb is fully deployed. (Figure 31)
NOTE: Tick marker on the contralateral limb of the distal bifurcated body is
used to determine anterior/posterior orientation of the contralateral limb. It
is not intended to line up with the anterior tick mark on the proximal body.

10.1.9 Contralateral Iliac Wire Guide Placement

1. Advance the contralateral catheter and wire guide into the common
iliac artery to a level below the short contralateral limb and then
manipulate the wire guide into the contralateral limb and into the
Distal Bifurcated Body. (Figure 32) AP and oblique fluoroscopic views
can aid in verification of device cannulation.
2. Advance the angiographic catheter into the body of the graft. Perform
angiography to confirm correct position inside the Distal Bifurcated
Body. Advance the catheter to where the proximal end of the Distal
Bifurcated Body is attached to the introducer.

10.1.10 Distal Bifurcated Body Deployment

1. Perform angiography to confirm proper position of the iliac leg with
respect to the internal iliac (hypogastric) artery. Adjust position if
necessary.
2. Withdraw sheath until the iliac leg is fully deployed.
3. 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 its slot over the
device inner cannula. (Figure 33) Stop withdrawing sheath.

10.1.11 Iliac Leg (Contralateral) Placement

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 limb 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 full iliac
leg stent (i.e., proximal stent of iliac leg graft) inside the contralateral
limb of the main body. (Figure 34) If there is any tendency for the
distal bifurcated body graft to move during this maneuver, hold it in
position by stabilizing the grey positioner on the distal bifurcated body
component (on the ipsilateral side).
NOTE: If di culty is encountered advancing the iliac leg delivery system,
exchange to a more supportive wire guide. In tortuous vessels the anatomy
may alter signi cantly 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 both internal iliac patency and
a minimum overlap of one full iliac leg stent (i.e., proximal stent of
iliac leg graft, maximum overlap of 1.5 stents) within the main body
endovascular graft.
5. To deploy, hold the iliac leg graft in position with the grey positioner
while withdrawing the sheath. (Figures 35a and 35b)
Ensure one stent 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, retract inner cannula to dock tapered dilator to
grey positioner. Tighten pin vise. Maintain sheath position while
withdrawing grey positioner with secured inner cannula. (Figure 36)
8. Re-check the position of the wire guide.
10.1.12 Distal Bifurcated Body Deployment
1. Remove the safety lock from the white trigger-wire release mechanism.
Withdraw and remove the trigger-wire by sliding the white trigger-wire
release mechanism off the handle and then remove via its slot over the
device inner cannula. (Figure 37)
2. Under fluoroscopy and after verification of iliac leg graft position,
loosen pin vise, retract inner cannula to dock tapered dilator to
grey positioner. Tighten pin vise. Maintain sheath position while
withdrawing grey positioner with secured inner cannula.
3. Re-check the position of the wire guides. Leave sheath and wire guide
in place.
4. Close the Captor Hemostatic Valve on the Flexor introducer sheath by
turning in a clockwise direction until hemostasis is achieved. (Figure 38)

10.1.13 Molding Balloon Insertion

1. Prepare Molding balloon as follows:
2. In preparation for the insertion of the molding balloon, open the
Captor Hemostatic Valve by turning it counter-clockwise.
3. Advance the Molding balloon over the wire guide and through the
Hemostatic Valve of the distal bifurcated body introduction system to
level of renal arteries. Maintain proper sheath positioning.
NOTE: Captor Hemostatic Valve may be utilized to assist with hemostasis by
turning in a clockwise rotation to the "close" position.
NOTE: Captor Hemostatic Valve should always be in the "open" position
when repositioning of molding balloon.
4. Expand the molding balloon with diluted contrast media (as directed
by the manufacturer) in the area of the suprarenal stent and the
infrarenal neck, starting proximally and working in the distal direction.
(Figure 39)
CAUTION: Prior to molding in the vicinity of any Fenestration stent(s)
confirm that the aortic section of the stent has been flared.
CAUTION: Confirm complete deflation of balloon prior to repositioning.
5. Withdraw the Molding balloon to the ipsilateral limb distal fixation site
and expand.
CAUTION: Do not inflate balloon in iliac vessel outside of graft.
6. Deflate and remove molding balloon. Transfer the 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.
7. Withdraw the molding balloon to the contralateral iliac leg/vessel distal
fixation and expand. (Figure 39)
CAUTION: Do not inflate balloon in iliac vessel outside of graft.
8. Remove molding balloon and replace it with an angiographic catheter
to perform completion angiograms.
9. Remove or replace all stiff wire guides to allow iliac arteries to resume
their natural position.
32