COOK Medical Zenith TX2 Gebrauchsanweisung Seite 13

10. Stabilize the grey positioner (delivery system shaft) and withdraw the sheath until the graft is fully
expanded and the valve assembly docks with the control handle.
CAUTION: As the sheath is withdrawn, anatomy and graft position may change. Constantly
monitor graft position and perform angiography to check position as necessary.
CAUTION: During sheath withdrawal, the proximal barbs are exposed and are in contact with
the vessel wall. At this stage it may be possible to advance the device, but retraction may cause
aortic wall damage.
NOTE: If extreme difficulty is encountered when attempting to withdraw the sheath, place the de-
vice in a less tortuous position which enables the sheath to be retracted. Very carefully withdraw
the sheath until it begins to retract, and stop. Move device back to original position and continue
deployment.
11. Verify graft position and adjust it forward, if necessary. Recheck graft position with angiography.
NOTE: If an angiographic catheter is placed parallel to the stent graft, use this to perform position
angiography.
12. Loosen the safety lock from the green trigger-wire release mechanism. Withdraw the trigger-wire
slowly until the proximal end of the graft opens. (Fig. 11) Withdraw the trigger-wire completely to
release the distal attachment to the introducer.
NOTE: Check to make sure that all trigger-wires are removed prior to withdrawal of the delivery
system.
13. Remove the introduction system, leaving the wire guide in the graft.
10.1.2 Placement of Distal Component
1. If an angiographic catheter in the femoral artery is in use, it should be withdrawn to a position to
demonstrate the aortic anatomy where the distal component is to be deployed.
2. Introduce the freshly hydrated delivery system over the wire guide until the desired graft position
is reached, with a recommended 3-4 stent overlap (75-100 mm), but no less than a 2 stent overlap
(50 mm) with the proximal component. Do not overlap proximal and distal sealing stents.
NOTE: To facilitate introduction of the wire guide into the delivery system, it may be necessary to
slightly straighten the delivery system dilator tip.
3. Check the position by angiography and adjust if necessary.
4. Ensure that the Captor Hemostatic Valve on the Flexor Introducer Sheath is turned counter-
clockwise to the open position. (Fig. 10)
5. Stabilize the grey positioner (delivery system shaft) and begin withdrawing the sheath.
CAUTION: As the sheath or wire guide is withdrawn, anatomy and graft position may change.
Constantly monitor graft position and perform angiography to check position as necessary.
NOTE: If extreme difficulty is encountered when attempting to withdraw the sheath, place the de-
vice in a less tortuous position which enables the sheath to be retracted. Very carefully withdraw
the sheath until it just begins to retract, and stop instantly. Move back to original position and
continue deployment.
6. Withdraw the sheath until the graft is fully expanded. Continue sheath withdrawal until the valve
assembly docks with the control handle.
7. Release the distal attachment by first unscrewing the trigger-wire safety lock on the white trigger-
wire release mechanism (labeled number "1"). (Figs. 12 and 13)
8. Unscrew and remove the safety lock on the telescoping handle (labeled number "2"). (Figs. 14 and 15)
9. Stabilize the delivery system and slide the telescoping handle together with the grey tube and
the outer sheath in a distal direction until the distal attachment stent is released. The telescoping
handle should be retracted as far as it will travel distally until it locks automatically into position.
(Fig. 16)
10. Loosen the safety lock from the green trigger-wire release mechanism. Withdraw the trigger-wire
slowly until the proximal end of the graft opens, then withdraw and remove the trigger-wire and
release mechanism (labeled number "3"). (Fig. 17)
NOTE: Check to make sure that all trigger-wires are removed prior to withdrawal of the delivery
system.
11. Remove the inner introduction system entirely, leaving the sheath and wire guide in the graft.
12. Close the Captor Hemostatic Valve on the Flexor Introducer Sheath by turning it in a clockwise
direction until it stops.
CAUTION: To avoid entangling any catheters left in situ, rotate the delivery system during with-
drawal.
10.1.3 Main Body Molding Balloon Insertion (Optional)
1. Prepare molding balloon as follows and/or per the manufacturer's instructions.
• Flush wire lumen with heparinized saline.
• Remove all air from balloon.
2. In preparation for the insertion of the molding balloon, open the Captor Hemostatic Valve by turn-
ing it counter-clockwise.
3. Advance the molding balloon over the wire guide and through the hemostatic valve of the main
body introduction system to the level of the proximal fixation/seal site. Maintain proper sheath
positioning.
4. Tighten the Captor Hemostatic Valve around the molding balloon with gentle pressure by turning
it clockwise.
CAUTION: Do not inflate balloon in the aorta outside of graft.
5. Expand the molding balloon with diluted contrast media (as directed by the manufacturer) in the
area of the proximal covered stent, starting proximally and working in the distal direction.
CAUTION: Confirm complete deflation of balloon prior to repositioning.
6. If applicable, withdraw the molding balloon to the proximal component/distal component overlap
and expand.
7. Withdraw the molding balloon to the distal covered stent and expand.
8. Open the Captor Hemostatic Valve, remove the molding balloon and replace it with an angio-
graphic catheter to perform completion angiograms.
9. Tighten the Captor Hemostatic Valve around the angiographic catheter with gentle pressure by
turning it clockwise.
10. Remove or replace all stiff wire guides to allow aorta to resume its natural position.
I-TX2-PRO-FORM-1002-361-02 ENGLISH 9