COOK Medical Zenith TX2 Gebrauchsanweisung Seite 15

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) Withdrawing the trigger-wire completely
will also 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 inner introduction system entirely, leaving the sheath and wire guide in the graft.
CAUTION: To avoid entangling any catheters left in situ, rotate the delivery system during with-
drawal.
14. Close the Captor Hemostatic Valve on the Flexor Introducer Sheath by turning it in a clockwise
direction until it stops.
Proximal Extension 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 Captor Hemostatic Valve of
the 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. Withdraw the molding balloon to the proximal extension/proximal component overlap and
expand.
7. Open the Captor Hemostatic Valve, remove the molding balloon and replace it with an angio-
graphic catheter to perform completion angiograms.
8. Tighten the Captor Hemostatic Valve around the angiographic catheter with gentle pressure by
turning it clockwise.
9. Remove or replace all stiff wire guides to allow aorta to resume its natural position.
Final Angiogram
1. Position angiographic catheter just above the level of the endovascular graft. Perform angiogra-
phy to verify correct positioning. Verify patency of arch vessels.
2. Confirm there are no endoleaks or kinks, and verify position of proximal gold radiopaque mark-
ers. Remove the sheaths, wires and catheters.
3. Repair vessels and close in standard surgical fashion.
10.2.2 Distal Extensions
Distal extensions are used for extending the distal end of an in situ endovascular graft or increasing the
length of overlap between graft components.
Distal Extension Preparation/Flush
1. Remove yellow-hubbed shipping stylet. Remove cannula protector tube. Remove Peel-Away
sheath from back of valve assembly. (Fig. 7)
2. Elevate distal tip of system and flush through the hemostatic valve until fluid emerges from the
tip of the introducer sheath. (Fig. 8) Continue to inject a full 20 cc of flushing solution through the
device. Discontinue injection and close stopcock on connecting tube.
NOTE: Ensure that the side-arm adapter is securely connected to the side of the valve body.
NOTE: Graft flushing solution of heparinized saline is often used.
3. Attach syringe with heparinized saline to the hub on the inner cannula. Flush until fluid exits the
distal sideports and dilator tip. (Fig. 9)
4. Soak 4X4 gauze pads with saline and use to wipe the Flexor introducer sheath to activate the
hydrophilic coating. Hydrate both sheath and dilator liberally.
Placement of the Distal Extension
1. Puncture the selected artery using standard technique with an 18 gage access needle. Upon ves-
sel entry, insert:
• Wire guide–standard .035 inch, 260 cm, 15 mm J tip or Bentson wire guide
• Appropriate size sheath (e.g., 5.0 French)
• Pigtail flush catheter (often radiopaque-banded sizing catheters; i.e., Cook Centimeter Sizing
CSC-20 catheter)
2. Perform angiography at the appropriate level. Using radiopaque markers, adjust position as
necessary and repeat angiography.
3. Ensure graft system has been primed with heparinized saline, and all air has been removed.
4. Give systemic heparin. Flush all catheters and wire guides with heparinized saline. This should be
repeated following each exchange.
5. Replace the standard wire guide with a stiff .035 inch, 300 cm–LESDC wire guide and advance
through the catheter and up to the aortic arch.
6. Remove pigtail flush catheter and sheath.
NOTE: At this stage, the second femoral artery can be accessed for flush catheter placement.
Alternatively, a brachial approach may be considered.
I-TX2-PRO-FORM-1002-361-02 ENGLISH 11