COOK Medical Zenith TX2 Gebrauchsanweisung Seite 14

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 and celiac plexus.
2. Confirm that there are no endoleaks or kinks, and verify position of proximal and distal gold
radiopaque markers. Remove the sheaths, wires and catheters.
NOTE: If endoleaks or other problems are observed, refer to Section 11.2, Ancillary Devices.
3. Repair vessels and close in standard surgical fashion.
10.2 Ancillary Devices
General Use Information
Inaccuracies in device size selection or placement, changes or anomalies in patient anatomy, or pro-
cedural complications can require placement of additional endovascular grafts and extensions. Re-
gardless of the device placed, the basic procedure(s) will be similar to the maneuvers required and
described previously in this document. It is vital to maintain wire guide access.
Standard techniques for placement of arterial access sheaths, guiding catheters, angiographic catheters
and wire guides should be employed during use of the Zenith TX2 TAA Endovascular Graft with Pro-
Form ancillary devices.
The Zenith TX2 TAA Endovascular Graft with Pro-Form ancillary devices with the Z-Trak Plus Introduc-
tion Systems are compatible with .035 inch diameter wire guides.
10.2.1 Proximal Extensions
Proximal extensions are used for extending the proximal body of an in situ endovascular graft.
Proximal 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 Proximal 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 introduction system has been primed with heparinized saline, and all air has been re-
moved.
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.
7. Introduce the freshly hydrated delivery system over the wire guide and advance until the desired
graft position is reached. Ensure there is a minimum overlap of 2 stents.
CAUTION: To avoid twisting the endovascular graft, never rotate the delivery system during the
procedure. Allow the device to conform naturally to the curves and tortuosity of the vessels.
NOTE: The dilator tip softens at body temperature.
NOTE: To facilitate introduction of the wire guide into the delivery system, it may be necessary to
slightly straighten the delivery system dilator tip.
NOTE: The proximal extension contains barbs which should not be placed within other graft
components.
8. Verify wire guide position in the aortic arch. Ensure correct graft position.
CAUTION: Care should be taken not to advance the sheath while the stent graft is still within it,
advancing the sheath at this stage may cause the barbs to perforate the introducer sheath.
9. Ensure that the Captor Hemostatic Valve on the Flexor Introducer Sheath is turned counter-
clockwise to the open position.
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 or wire guide 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 just begins to retract, and stop instantly. Move back to original position and
continue deployment.
10 ENGLISH I-TX2-PRO-FORM-1002-361-02