General Use Information; Pre-Implant Determinants; Patient Preparation; The Zenith Alpha Thoracic Endovascular Graft Preparation/Flush - Proximal And Distal Components - COOK Medical ZENITH ALPHA Mode D'emploi

Prior to use of the Zenith Alpha Thoracic Endovascular Graft, review this
Suggested Instructions for Use booklet. The following 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 Alpha Thoracic Endovascular Graft. The Zenith Alpha Thoracic
Endovascular Graft is compatible with .035 inch diameter wire guides.
Endovascular stenting is a surgical procedure, and blood loss from various
causes may occur, infrequently requiring intervention (including transfusion)
to prevent adverse outcomes. It is important to monitor blood loss from the
hemostatic valve throughout the procedure, but is specifically relevant during
and after manipulation of the gray positioner. After the gray positioner has been
removed, if blood loss is excesssive, consider placing an uninflated molding
balloon or an introduction system dilator within the valve, restricting flow.

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 introduction 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 the patient on the 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 The Zenith Alpha Thoracic Endovascular Graft
Preparation/Flush – Proximal and Distal Components
1. Remove the yellow-hubbed inner stylet from the dilator tip. Verify that the
Captor Sleeve is inserted in the Captor Hemostatic Valve; do not remove the
Captor Sleeve (fig. 4).
2. Elevate the distal tip of the system and flush through the hemostatic valve
(fig. 5) until fluid emerges from the tip of the introducer sheath. Continue
to inject a full 60 cc of flushing solution through the device. Discontinue
injection and close the stopcock on the connecting tube.
NoTE: Graft flushing solution of heparinized saline is often used.
3. Attach a syringe with heparinized saline to the hub on the rotation handle
(fig. 6). Flush until fluid exits the distal sideports and dilator tip.
4. Soak sterile gauze pads in saline solution and use them to wipe the Flexor
Introducer Sheath to activate the hydrophilic coating. Hydrate both sheath
and dilator tip liberally.

10.1.1 Placement of Proximal Component

1. Puncture the selected artery using standard technique with an 18 gage
access needle. Upon vessel entry, insert:
• Wire guide – standard .035 inch, 260/300 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 position as necessary and repeat angiography.
3. Ensure the 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
heparinized saline. 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 the 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 introduction system over the wire guide and
advance until the desired graft position is reached.
CaUTIoN: To avoid twisting the endovascular graft, never rotate the
introduction 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.
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. 7).
10. Stabilize the gray positioner (introduction system shaft) and withdraw the
sheath until the graft is fully expanded and the valve assembly with the
Captor Sleeve docks with the black gripper (fig. 8).
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 device in a less tortuous position that enables the
sheath to be retracted. Very carefully withdraw the sheath until it just
begins to retract, and stop. Move 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. While holding the black gripper, turn the black safety lock knob in the
direction of the arrows to engage the blue rotation handle (fig. 9).
13. Under fluoroscopy, turn the blue rotation handle in the direction of the
arrow until a stop is felt (fig. 10). This indicates that the uncovered stent
and proximal end of the graft have opened, and the distal attachment to
the introducer has been released.
NoTE: If difficulty is encountered during rotation of the blue rotation
handle, refer to Section 12 RELEaSE TRoUbLESHooTING for instructions
on how to disassemble the rotation handle.
14. Remove the introduction system, leaving the wire guide in the graft.
CaUTIoN: To avoid entangling any catheters left in situ, rotate the
introduction system during withdrawal.
I-ALPHA-TAA-1306-436-01

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 introduction system over the wire guide
until the desired graft position is reached, with a minimum recommended
three-stent overlap (75 mm) with the proximal component. No part of the
distal component should overlap the proximal seal stent of the proximal
component, and no part of the proximal component should overlap
the distal seal stent of the distal component, as doing so may cause
malapposition to the vessel wall.
NoTE: To facilitate introduction of the wire guide into the introduction
system, it may be necessary to slightly straighten the introduction 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. 7).
5. Stabilize the gray positioner (introduction system shaft) and begin
withdrawing the sheath.
CaUTIoN: as the sheath 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 device in a less tortuous position that enables the
sheath to be retracted. Very carefully withdraw the sheath until it just
begins to retract, and stop. 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 with the Captor Sleeve docks with the
telescoping black gripper (fig. 11).
7. To release the distal attachment, hold the black gripper and turn the black
safety lock knob on the rotation handle in the direction of the arrow (fig.
12). Turn the rotation handle in the direction of the arrow next to label 1
until a stop is felt (fig. 10).
8. Turn the gray safety lock knob indicated by label 2, on the black sliding
gripper in the direction of the arrow (fig. 14).
9. To release the distal bare stent, stabilize the introduction system and slide
the black sliding gripper over the gray tube and outer sheath in a distal
direction until it locks automatically into position next to the blue rotation
handle (fig. 15). The release window on the handle next to label 3 will turn
green (fig. 16).
10. If the bare stent cannot be fully deployed from the cap, complete
the deployment procedure and refer to section 12 RELEaSE
TRoUbLESHooTING.
11. Turn the blue rotation handle in the direction of the arrow, label 3 until a
stop is felt and the proximal end of the graft opens.
If difficulty is encountered rotating the blue rotation handle, refer to
Section 12 RELEaSE TRoUbLESHooTING for instructions on how to
disassemble the rotation handle.
12. Remove the inner introduction system entire ly, leaving the sheath and wire
guide in the graft.
13. 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
introduction system during withdrawal.
10.1.3 Main Body Molding Balloon Insertion — Optional
1. Prepare molding balloon as follows and/or per the manufacturer's
instructions.
• Flush the wire lumen with heparinized saline.
• Remove all air from the balloon.
2. In preparation for insertion of the molding balloon, open the Captor
Hemostatic Valve by turning it counter-clockwise (fig. 7).
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 the 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 fixation site and expand.
8. Open the Captor Hemostatic Valve, remove the molding balloon
and replace it with an angiographic 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 the aorta to resume its
natural position.

Final Angiogram

1. Position angiographic catheter just above the level of the endovascular
graft. Perform angiography 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 10.2,

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 procedural complications can require placement of
additional endovascular grafts and extensions. Regardless 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 Alpha Thoracic Endovascular Graft ancillary devices.
The Zenith Alpha Thoracic Endovascular Graft ancillary devices are compatible
with .035 inch diameter wire guides. Additional proximal main body
components may be used to extend graft coverage proximally.

10.2.1 Distal Extensions

Distal extensions are used to extend the distal body of an in situ endovascular
graft or increase the length of overlap between graft components.
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