Additional Surveillance And Treatment; Trigger-Wire Release Troubleshooting; Alternate Proximal Body Deployment; Docking Of Top Cap - COOK Medical Zenith Fenestrated AAA Instructions For Use Manual

11.6 Additional Surveillance and Treatment

Additional surveillance and possible treatment is recommended for:
endoleak status)
Consideration for reintervention or conversion to open repair should
include the attending physician's assessment of an individual patient's co-
morbidities, life expectancy and the patient's personal choices.
Patients should be counseled that subsequent reinterventions including
catheter based and open surgical conversion are possible following
endograft placement.

12 TRIGGER-WIRE RELEASE TROUBLESHOOTING

CAUTION: The following steps should be performed only if unable
to remove the proximal trigger-wire as described in Section 10.1.5,
Proximal Body Placement (14).
NOTE: Technical assistance from a Cook product specialist may be obtained
by contacting your local Cook representative.

12.1 Alternate Proximal Body Deployment

1. Cut the exposed suprarenal stent trigger-wire between the white and
black release mechanisms (Figure 40) and remove the black release
mechanism from the handle.
2. Remove the safety lock from the white (distal) trigger-wire release
mechanism.
3. Withdraw the white trigger-wire release mechanism and then remove
via its slot over the device inner cannula.
NOTE: This will detach the distal end of the graft from the grey positioner.
4. Using locking forceps, clamp and secure the cut end of the suprarenal
stent trigger-wire. (Figure 41)
5. Loosen the pin vise and, while maintaining inner cannula and trigger-
wire 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 42).
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.
NOTE: Maintain gentle tension on the suprarenal stent trigger-wire to
remove any slack in the wire as the grey positioner and sheath are being
advanced.
6. Lock the pin vise. Confirm that the suprarenal stent trigger-wire is
secured by the forceps.
7. Stabilize the grey positioner and slowly advance the sheath until the
sheath tip is 2 mm from the gold markers. (Figure 43)
NOTE: Take care when advancing the sheath as there will be other sheaths
and wire guides positioned in target vessels. Take care not to advance the
graft itself during sheath advancement.
8. Stabilize the sheath and slightly retract the grey positioner with inner
cannula to move the top cap down over the suprarenal stent.
(Figure 44)
NOTE: Avoid compressing the body of the graft.
9. Ensure the fenestrations are positioned correctly. Test the resistance on
the trigger wire and make minor adjustments as necessary to reduce
trigger wire resistance (Section 12.1, 8).
10. Remove the suprarenal stent trigger-wire.
11. Withdraw the sheath until the tapered tip of the grey positioner is
exposed.
12. If there are multiple fenestrations, withdraw all but one of the
fenestration guiding catheters. It is the physician's preference as
to which guiding catheter to withdraw. It is recommended that
the decision be made based on the ease of cannulation of the
fenestrations and their respective vessels. (Figure 45)
NOTE: Leave the wire guides in place when removing the guiding
catheter(s).
12. (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.
13. 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.
14. Inflate the balloon to the full diameter of the graft. (Figure 46)
15. Loosen the pin vise (Figure 47). 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.
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 48 and 49). Advance the
top cap cannula an additional 1 to 2 cm and then retighten the pin vise
(Figure 50) 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. If there are multiple fenestrations (Section 12.1, 12), deflate the
balloon then withdraw it leaving the wire guide in place
17. (a) If there is a single fenestration (Section 12.1, 12a), 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, which remain in the target vessel
18. 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 51)
NOTE: Check to make sure that all trigger-wires are removed prior to
withdrawal of the delivery system.

12.2 Docking of Top Cap

1. Loosen the pin vise. (Figure 52)
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 53, 54 and 55)
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 56) Leave the sheath and wire guide in place.
5. Close the Captor Hemostatic Valve on the Flexor introducer sheath by
turning it in a clockwise direction until it stops.
6. Return to Section 10.1.7, Fenestration Stent Placement and
Deployment.

13 SUPRARENAL STENT DEPLOYMENT TROUBLESHOOTING

CAUTION: The following steps should be performed only if unable to
deploy the suprarenal stent by advancing the top cap as described in
Section 10.1.5, Proximal Body Placement (15).
NOTE: Technical assistance from a Cook product specialist may be obtained
by contacting your local Cook representative.

13.1 Proximal Body Placement with distal attachment

If the suprarenal stent cannot be fully deployed by advancing the top cap
inner cannula, perform the following steps under uoroscopy.
1. Tighten the pin-vice. If there are multiple fenestrations, withdraw all but
one of the fenestration guiding catheters. It is the physician's preference
as to which guiding catheter to withdraw. It is recommended that the
decision be made based on the ease of cannulation of the fenestrations
and their respective vessels. (Figure 57)
(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 58)
4. Loosen the pin vise. (Figure 59)
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 60 and 61) Advance the
top cap cannula an additional 1 to 2 cm and then retighten the pin vise
(Figure 62) 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 63)
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 10.1.6 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 64)
3. Loosen the pin vise (Figure 65) 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 66).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 67)
7. Loosen the pin vise (Figure 68). 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.
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