2011/DEC/22 at 7:46 p.m. Doc number: M716803B001 [multi23]
Note: Retract the graft cover past the flexible stent stop tip (approximately 10 mm) to ensure the graft
cover edge does not disturb the graft position during forward advancement of the delivery system for tip
recapture.
Caution: When using the trigger to rapidly deploy the stent graft, be sure to hold the delivery system
stationary. Do not rotate the delivery system during this step.
Figure 12. Deploy the Distal End of Bifurcated Component
Note: Graphic representation not to scale
9.7.7. Recapture Spindle Within Sleeve of the Taper Tip
Continue to hold the Endurant Aortic Delivery System with one hand on the front grip. If the spindle has
not fully separated from the crowns of the suprarenal stent, gently torque the delivery system. Gently
torque in one direction (even making several full rotations if necessary) and push the entire delivery system
proximally approximately 3 cm so that the taper tip and spindle are completely clear of the suprarenal
stent. With the other hand, rotate the back-end wheel counter-clockwise capturing the spindle in the taper
tip as depicted in Figure 13. Observe the capture of the spindle within the sleeve of the taper tip under
fluoroscopy. Continue turning the back-end wheel counter-clockwise until the spindle has been completely
captured and the back-end wheel is at the bottom of the back-end screw gear.
Note: Ensure that the ipsilateral limb is fully deployed before advancing the delivery system.
Note: Ensure that the suprarenal stent is fully disengaged from the spindle before pushing the Delivery
System forward.
Note: If the spindle catches on the suprarenal stent during advancement, completely advance the back-
end wheel clockwise. Using a gentle in-and-out motion with the delivery system, rotate the delivery system
until the spindle slips past the suprarenal stent. Then continue with the withdrawal instructions.
Note: It is recommended that the angiographic catheter be pulled down before recapturing the spindle
within the sleeve of the taper tip.
Caution: The spindle must be recaptured within the taper tip sleeve in order to prevent complications.
Caution: Make sure to stop rotating the back-end wheel when you reach the bottom of the back-end screw
gear.
Warning: FAILURE TO ADEQUATELY ADVANCE THE DELIVERY SYSTEM TO RECAPTURE THE
SPINDLE CAN RESULT IN THE TRAPPING OF A SUPRARENAL CROWN WITHIN THE TAPER TIP
SLEEVE AND RESULT IN AN ALTERATION OF THE PROXIMAL LANDING ZONE UPON ATTEMPTED
WITHDRAWAL.
Figure 13. Recapture Spindle Within Sleeve of the Taper Tip
Note: Graphic representation not to scale
9.7.8. Delivery System Removal
Continue to hold the Endurant Aortic Delivery System with one hand on the front grip and the other hand
on the slider. Gently torque in one direction and withdraw the delivery system until the spindle is retracted
into the fabric portion of the stent graft. Pull back the slider trigger and hold the slider stationary while
bringing the front grip to the slider as depicted in Figure 14. Use continual fluoroscopy and watch the top
of the Bifurcated Stent Graft Component while slowly pulling back the taper tip into the graft cover of the
delivery system.
Gently remove the delivery system using fluoroscopy to ensure that the stent graft component does not
move during the withdrawal.
Note: Maintain vessel access until all stent graft components are in place.
Note: If the spindle portion becomes stuck at the proximal fabric section despite repeated torquing,
advance the entire delivery system forward approximately 1 cm, then pull down the guidewire such that
the flexible portion is located within the delivery system tip. Gently pull down the delivery system while
torquing until the spindle has cleared the proximal fabric section. Re-advance the guidewire and gently
remove the delivery system.
Note: If tip sleeve/spindle become stuck inside the stent graft during withdraw, check to see if the wheel
is in the back position and the spindle was correctly recaptured. If it was not, hold the gray handle stationary
and retract the graft cover until the graft cover RO marker band is approximately 10 mm past the stent
stop. Gently torque and advance the delivery system until the spindle is 3 cm past the suprarenal stent.
Follow the standard instructions for delivery system removal and rotate the backend wheel
counterclockwise until the arrow is returned to the screw gear.
18
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