Proximal Body Placement Without Distal Attachment - COOK Medical Zenith Fenestrated Mode D'emploi

(a) If there is a single fenestration, then the proximal body needs to
be cannulated with a suitable wire guide from the same side as
the in-situ guide catheter. This is to allow placement of a molding
balloon within the proximal body.
NOTE: Leave the wire guides in place when removing the guiding
catheter(s).
2. Advance a molding balloon along the now available wire guide into
the proximal body and position it just superior to the distal-most end
of the graft.
NOTE: When using the molding Balloon, ensure the appropriate sheath
is used – either through the in-situ 20 Fr Contralateral sheath or, if direct
punctures have been used, through a 14 Fr introducer sheath. This will
ensure the safe retrieval of the molding balloon.
3. To add support to the inner cannula, inflate the balloon to the full
diameter of the graft. (Figure 57)
4. Loosen the pin vise. (Figure 58)
5. Control the position of the graft by stabilising the grey positioner and
balloon catheter.
CAUTION: Before deployment of the 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.
6. 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 59 and 60) Advance the
top cap cannula an additional 1 to 2 cm and then retighten the pin vise
(Figure 61) to avoid contact with the deployed suprarenal stent.
NOTE: Care should be taken during removal to not disturb the guide
sheath and wire guide(s), which remain in the target vessel(s).
If the suprarenal stent is fully deployed:
7. a) If there are multiple fenestrations (Section 13.1, 1), deflate the
balloon then withdraw it leaving the wire guide in place. Advance the
access sheath and aligning stent, which was removed to facilitate the
molding balloon, back over the wire guide, through the fenestration
and into the respective vessel. (Figure 62)
b) If there is a single fenestration (Section 13.1, 1a), then the molding
balloon and wire guide can be safely removed.
NOTE: Care should be taken during removal to not disturb the guide
sheath and wire guide(s), which remain in the target vessel(s).
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.
8. Return to Section 10.1.5 Docking of Top Cap.

13.2 Proximal Body Placement without distal attachment

If still unable to fully deploy the suprarenal stent, perform the following steps:
1. Tighten the pin vise and deflate the balloon, while maintaining balloon
position.
2. 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 trigger-wire
release mechanism off the handle and remove via its slot over the
device inner cannula. (Figure 63)
3. Loosen the pin vise (Figure 64) and, while maintaining inner cannula
position, advance the grey positioner and sheath into the graft until
the tip of the grey positioner is approximately 2 cm from the gold
markers on the proximal edge of the proximal body (Figure 65).The
advanced grey positioner provides added support to the inner cannula.
NOTE: Take care when advancing the grey positioner as there will be
sheaths and wire guides positioned in target vessels. Ensure that the tip of
the grey positioner is not advanced into the top cap.
4. Lock the pin vise.
5. Verify position of the gold markers and ensure the fenestrations are
positioned correctly.
6. To add support to the inner cannula, inflate the balloon to the full
diameter of the graft. (Figure 66)
7. Loosen the pin vise (Figure 67). Control the position of the graft by
stabilising the grey positioner and balloon catheter.
CAUTION: Before deployment of the 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.
8. 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 68 and 69). Advance the
top cap cannula an additional 1 to 2 cm and then retighten the pin vise
(Figure 70) to avoid contact with the deployed suprarenal stent.
NOTE: Care should be taken during removal to not disturb the guide
sheath and wire guide(s), which remain in the target vessel(s).
9. a) If there are multiple fenestrations (Section 13.1, 1), deflate the
balloon then withdraw it leaving the wire guide in place. Advance
the access sheath and aligning stent, which was removed to
facilitate the molding balloon, back over the wire guide, through the
fenestration and into the respective vessel. (Figure 71)
b) If there is a single fenestration (Section 13.1, 1a), then the molding
balloon and wire guide can be safely removed.
NOTE: Care should be taken during removal to not disturb the guide
sheath and wire guide(s), which remain in the target vessel(s).
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.
10. Return to Section 10.1.5, Docking of Top Cap.
NOTE: Check to make sure that all trigger-wires are removed prior to
withdrawal of the delivery system.
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