The Zenith ® Tx2 ® Dissection Endovascular Graft With Pro-Form - COOK Medical Zenith TX2 Instrucciones De Uso

11.1
The Zenith TX2 Dissection Endovascular
Graft with Pro-Form and the Z-Trak Plus
Intro d uction System
Preparation/Flush
Fig. 5
1. Remove yellow-hubbed shipping stylet (from
the inner cannula) and cannula protector
tube (at the handle). Remove Peel-Away
sheath from back of valve assembly (Fig. 5).
Fig. 6
2. Elevate distal tip of system and flush through
the hemostatic valve until fluid emerges from
the tip of the introduction sheath (Fig. 6).
Continue to inject a full 60 cc of flushing solu-
tion through the device. Discontinue injection
and close stopcock on connecting tube.
NOTE: Graft flushing solution of heparinized
saline is often used.
Fig. 7
3. Attach syringe with heparinized saline to the
hub on the inner cannula. Flush until fluid
exits the distal sideports and dilator tip
(Fig. 7).
10 ENGLISH
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.
11.1.1
Placement of The Zenith TX2
Dissection Endovascular Graft with
Pro-Form and the Z-Trak Plus Introduction
System
1. Puncture the selected artery using standard
technique with an 18 gauge access needle.
Upon vessel 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. If using radiopaque markers, adjust po-
sition as necessary and repeat angiography.
3. Ensure graft system has been flushed and
primed with heparinized saline (appropriate
flush solution), and all air has been removed.
4. Give systemic heparin. Flush all catheters
and wet all wire guides with a strong heparin
solution. This should be repeated following
each exchange.
5. Replace the standard wire guide with a stiff
.035 inch, 260/300 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 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.
CAUTION: To avoid twisting the endovas-
cular graft, never rotate the delivery system
during the procedure. Allow the device to
conform naturally to the curves and tortuos-
ity 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.
Fig. 8
9. Ensure that the Captor Hemostatic Valve on
the Flexor Introducer Sheath is turned to the
open position (Fig. 8).
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.
N OTE: If extreme difficulty is encountered
when attempting to withdraw the sheath,
place the device in a less tortuous position
which enables the sheath to be retracted.
I-ZDEG-EU-1105-394-02