Docking Of Top Cap; Fenestration Stent Placement And Deployment; Distal Bifurcated Body Placement; Contralateral Iliac Wire Guide Placement - COOK Medical Zenith Fenestrated Mode D'emploi

7. Verify position of the wire guide in the thoracic aorta. Ensure that
fenestration(s) and/or scallops are at the level of the appropriate arteries
and the anterior markers are in the most anterior (12:00 o'clock) position.
NOTE: The vertical anterior markers, and the horizontal posterior markers
should form a cross, on the uoroscopic image, when correctly oriented.
(Figure 15b)
NOTE: The fenestration/scallop markers should be in close apposition to
the appropriate side branch vessels.
NOTE: Ensure the Captor Hemostatic Valve on the Flexor introducer sheath
is turned to the open position. (Figure 16)
Clear identi cation of fenestration position(s) may not be possible until the
graft has been fully unsheathed.
8. 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.
9. Perform angiography, and adjust graft placement as necessary.
Continue to withdraw the sheath making positional adjustments as
necessary.
NOTE: Techniques to ensure that the fenestration(s) and/or scallop(s) will
accurately align with their respective vessels will vary, and will depend
upon vessel anatomy, graft design, and physician preferences.
10. Proceed with deployment until the graft has been fully unsheathed.
(Figure 17)
11. When a satisfactory graft position has been achieved, withdraw the
angiographic catheter and wire guide, then exchange to selective
wire guide/selective catheter to below the level of the proximal body.
Cannulate the partially deployed proximal main body.
NOTE: If a small fenestration is being utilised, care should be taken to
properly align the fenestration with the respective vessel.
12. Utilising contralateral access sheath and wire guide, cannulate and
advance a guiding catheter into each small fenestration and its respective
vessel. (Figure 18)
NOTE: Non-compliant angioplasty balloons may be used as an alternative
to guiding catheters.
NOTE: Cannulation of the scallop and its respective vessel may also be
achieved using similar techniques.
NOTE: It is not recommended to use balloons or guiding catheters to guide
nal placement of large fenestrations as stent struts across fenestration
may interfere.
CAUTION: Before release of the diameter reducing ties, verify that the
position of the ipsilateral access wire extends just distal to the aortic
arch.
CAUTION: During proximal trigger-wire removal, top cap
advancement, and subsequent suprarenal stent deployment, verify
that the position of the main body wire guide extends just distal to the
aortic arch and that support of the system is maximized.
13. Verify proper position of proximal body. Remove the safety lock from
the gold trigger-wire release mechanism. Withdraw and remove the
trigger-wire to release diameter reducing ties by sliding the gold
trigger-wire release mechanism off the handle and then remove via its
slot over the inner cannula. (Figure 19)
NOTE: At this point, the proximal main body graft should be fully expanded
with the proximal bare stent contained within the top cap.
14. Remove the safety lock from the black trigger-wire release mechanism.
Under fluoroscopy, withdraw and remove the trigger-wire to unlock
the suprarenal stent from the top cap by sliding the black trigger-wire
release mechanism off the handle and then remove via its slot over the
inner cannula. (Figure 20)
NOTE: If resistance is felt or system bowing is noticed, the trigger-wire is
under tension. Excessive force may cause the graft position to be altered. If
excessive resistance or delivery system movement is noted, stop and assess
the situation.
If unable to remove the black trigger-wire release mechanism from the top
cap, perform the following steps under uoroscopy:
a. Remove tension on the trigger-wire by loosening the pin vise and slightly
ulling the inner cannula to move the top cap down over the suprarenal
stent. Avoid compressing the Zenith Fenestrated proximal body.
b. Retighten the pin vise.
c. Remove the black trigger-wire release maechanism.
d. Continue with (15) in Section 10.1.4 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 21) 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 22a and 22b) 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 23)
NOTE: Check to make sure that all trigger-wires are removed prior to
withdrawal of the delivery system.

10.1.5 Docking of Top Cap

1. Loosen the pin vise. (Figure 24)
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 25a, 25b and 25c)
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 26) Leave the sheath and wire guide in place.
5. Close the Captor Hemostatic Valve by turning it in a clockwise direction
until it stops.

10.1.6 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 27)
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 28)
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.

10.1.7 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 29)
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:
• The degree of overlap with proximal body (no less than 2 stents)
• The position of the contralateral limb
• The position of the ipsilateral iliac cuff with respect to the common
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. (Figure16)
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 30)
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.

10.1.8 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 31) 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.

10.1.9 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 32) Stop withdrawing sheath.

10.1.10 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 33) 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).
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