COOK Medical Zenith TX2 Gebrauchsanweisung Seite 12

Proximal and Distal Component Overlap
A minimum overlap of 2 stents (~50 mm) is required; a 3-4 stent (~75-100 mm) overlap is recommend-
ed, however, the proximal sealing stent of the proximal component or distal sealing stent of the distal
component should not be overlapped.
The following instructions embody a basic guideline for device placement. Variations in the following
procedures may be necessary. These instructions are intended to help guide the physician and do not
take the place of physician judgment.
General Use Information
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 with the Z-Trak Plus Introduction System. The Zenith TX2 TAA Endovascular Graft with Pro-Form
with the Z-Trak Plus Introduction System is compatible with .035 inch diameter wire guides.
Pre-Implant Determinants
Verify from pre-implant planning that the correct device has been selected. Determinants include:
1. Femoral artery selection for introduction of the delivery system(s)
2. Angulation of aorta, aneurysm and iliac arteries
3. Quality of the proximal and distal fixation sites
4. Diameters of proximal and distal fixation sites and distal iliac arteries
5. Length of proximal and distal fixation sites
Patient Preparation
1. Refer to institutional protocols relating to anesthesia, anticoagulation, and monitoring of vital
signs.
2. Position patient on imaging table allowing fluoroscopic visualization from the aortic arch to the
femoral bifurcations.
3. Expose femoral artery using standard surgical technique.
4. Establish adequate proximal and distal vascular control of femoral artery.
10.1 Zenith TX2 TAA Endovascular Graft with Pro-Form System Component
Preparation/Flush/Placement – Proximal and Distal Components
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 in saline solution and use to wipe the Flexor Introducer Sheath to activate
the hydrophilic coating. Hydrate both sheath and dilator liberally.
10.1.1 Placement of Proximal Component
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 flushed and primed with heparinized saline (appropriate flush solu-
tion), and all air has been removed.
4. Give systemic heparin. Flush all catheters and wet all 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 angiographic catheter place-
ment. 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.
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 will soften 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.
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 to the open
position. (Fig. 10)
8 ENGLISH
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I-TX2-PRO-FORM-1002-361-02