COOK Medical Zenith Flex, Instructions For Use Manual

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Clinical information is available for seventeen patients who received MRI scans
after stent-graft implantation. There have been no reported adverse events
or device problems in any of these patients as a result of having received an
MRI. Additionally, there have been well over 100,000 Zenith AAA Endovascular
Grafts implanted worldwide, in which there have been no reported adverse
events or device problems as a result of MRI.
Cook recommends that the patient register the MR conditions disclosed in
this IFU with the MedicAlert Foundation. The MedicAlert Foundation can be
contacted in the following manners.
Mail: MedicAlert Foundation International
2323 Colorado Avenue
Turlock, CA 95382
Phone: 888-633-4298 (toll free)
209-668-3333 from outside the US
Fax: 209-669-2450
Web: www.medicalert.org
12.6 Additional Surveillance and Treatment
Additional surveillance and possible treatment is recommended for:
• Aneurysms with Type I endoleak
• Aneurysms with Type III endoleak
• Aneurysm enlargement, ≥5 mm of maximum diameter (regardless of
endoleak status)
• Migration
• Inadequate seal length
Consideration for reintervention or conversion to open repair should include
the attending physician's assessment of an individual patient's co-morbidities,
life expectancy and the patient's personal choices. Patients should be
counseled that subsequent reinterventions including catheter based and open
surgical conversion are possible following endograft placement.
13 PATIENT TRACKING INFORMATION
In addition to these Instructions for Use , the Zenith Flex AAA Endovascular
Graft with the Z-Trak Introduction System is packaged with a Device Tracking
Form which the hospital staff is required to complete and forward to COOK
for the purposes of tracking all patients who receive the Zenith Flex AAA
Endovascular Graft (as required by U.S. Federal Regulation).
14 TROUBLESHOOTING
NOTE: Technical assistance from a Cook product specialist may be obtained by
contacting your local Cook representative.
14.1 Trigger Wire Release Troubleshooting
CAUTION: The following steps should be performed only if unable to
remove the proximal trigger-wire as described in Section 11.1.7.
14.1.1 Main Body Proximal (Top) Deployment
1. If the top stent trigger-wire release mechanism cannot be removed from
the handle, cut the wire adjacent to the release mechanism (Fig. 32) and
remove the release mechanism from the handle.
2. Stabilize the gray positioner while withdrawing the sheath to fully deploy
the ipsilateral limb.
3. Remove the safety lock from the ipsilateral limb trigger-wire release
mechanism.
4. Withdraw and remove the trigger-wire by sliding the ipsilateral limb
trigger-wire release mechanism off the handle, and then remove via its
slot over the device inner cannula.
5. Using locking forceps, clamp and secure the cut end of the top cap
trigger-wire. (Fig. 33)
6. Loosen the pin vise and, while maintaining inner cannula and trigger-wire
position, advance the gray positioner and sheath into the graft until the
tip of the gray positioner is approximately 2 cm from the gold markers.
(Fig. 34) The advanced gray positioner provides added support to the
inner cannula.
NOTE: Maintain gentle tension on the trigger-wire to remove any slack in the
wire as the gray positioner and sheath are being advanced.
NOTE: Ensure that the tip of the gray positioner is not advanced into the
top cap.
7. Lock the pin vise. Confirm that the trigger-wire is secured to the forceps.
8. Stabilize the gray positioner and slowly advance the sheath until the sheath
tip is 2 mm from the gold markers. (Fig. 35)
NOTE: Take care not to advance the graft itself during sheath advancement.
9. Stabilize the sheath and retract the gray positioner with inner cannula to
draw the top cap over the suprarenal stent. (Fig. 36)
10. Verify position of the gold markers inferior to the renal arteries.
11. Remove the trigger-wire.
12. Withdraw the sheath until the tapered tip of the gray positioner is
exposed.
13. Advance a molding balloon through the contralateral limb of the main
body and position it just superior to the graft bifurcation.
14. Inflate the balloon to the full diameter of the graft. (Fig. 37)
15. Loosen the pin vise.
16. Stabilize the gray positioner and balloon catheter, and advance the inner
cannula to deploy the top cap.
17. Tighten the pin vise.
18. Deflate the balloon and advance the contralateral wire guide into the
thoracic aorta.
NOTE: Due to early ipsilateral leg deployment and trigger-wire release, it is
suggested to leave the molding balloon in or just above the contralateral limb
for graft stabilization during placement of the ipsilateral limb.
14.1.2 Docking of Top Cap
1. Loosen the pin vise. (Fig. 22)
2. Secure sheath and inner cannula to avoid any movement of these
components.
3. Advance the gray positioner over the inner cannula until it docks with the
top cap. (Figs. 23, 24 and 38)
NOTE: If resistance occurs, slightly rotate gray positioner and continue to
gently advance.
4. Retighten the pin vise and withdraw the entire top cap and gray
positioner through the graft and through the sheath by pulling on the
inner cannula. (Fig. 39) Leave the sheath and wire guide in place.
5. Close the Captor Hemostatic Valve on the Flexor introducer sheath by
turning it in a clockwise direction until it stops. (Fig. 26)
14.1.3 Ipsilateral Iliac Leg Placement and Deployment
NOTE: Ensure that the Captor Hemostatic Valve on the introducer sheath is
turned to the open position. (Fig. 27)
1. Utilize the main body graft wire and sheath assembly to introduce the
ipsilateral leg graft.
NOTE: Due to top cap release modification, the main body sheath assembly
must be withdrawn to a point 1-2 cm inside the proximal ipsilateral limb.
Advance the dilator sheath assembly of the ipsilateral limb into the main body
sheath.
NOTE: The molding balloon may be inflated in the contralateral limb of the
main body graft if additional graft stabilization is necessary.
CAUTION: Do not inflate the balloon outside of the graft.
NOTE: In tortuous vessels, the position of the internal iliac arteries may alter
significantly with the introduction of the rigid wires and sheath systems.
2. Advance slowly until the ipsilateral iliac leg graft overlaps a minimum
of one full iliac leg stent (i.e., proximal stent of iliac leg graft) inside the
ipsilateral limb of the main body. (Fig. 40)
NOTE: If an overlap of greater than three iliac leg stents is required (greater
than two iliac leg stents for 37, 39, 54 and 56 mm leg lengths), it may be
necessary to consider use of a leg extension in the bifurcation area of the
opposite side.
3. Confirm position of distal end of the iliac leg graft. Reposition the iliac leg
graft if necessary to ensure internal iliac patency.
4. To deploy, stabilize the iliac leg graft with the gray positioner while
withdrawing the iliac leg sheath and main body sheath together.
(Figs. 29 and 41) If necessary, withdraw the main body sheath.
5. Under fluoroscopy and after verification of iliac leg graft position, loosen
the pin vise, and retract the inner cannula to dock the tapered dilator
to the gray positioner. Tighten pin vise. Maintain sheath position while
withdrawing gray positioner with secured inner cannula. (Fig. 42)
6. Close the Captor Hemostatic Valve on the Flexor introducer sheath by
turning it in a clockwise direction until it stops.
7. Re-check the position of the wire guides. Leave sheath and wire guides in
place.
8. Remove deflated balloon from contralateral side.
14.1.4 Contralateral Iliac Leg Placement and Deployment
CAUTION: Verify the predetermined contralateral iliac leg is selected for
insertion on the contralateral side of the patient before implantation.
1. Position the image intensifier to show both the contralateral internal iliac
artery and contralateral common iliac artery.
2. Prior to introduction of contralateral iliac leg delivery system, inject
contrast through the contralateral femoral sheath to locate the
contralateral internal iliac artery.
3. Introduce the contralateral iliac leg delivery system into the artery.
Advance slowly until the iliac leg graft overlaps at least one full iliac leg
stent (i.e., proximal stent of iliac leg graft) inside the contralateral limb of
the main body. (Fig. 43)
NOTE: If difficulty is encountered advancing the iliac leg delivery system,
exchange to a more supportive wire guide. In tortuous vessels, the anatomy
may alter significantly with the introduction of the rigid wires and sheath
systems.
4. Confirm position of distal end of the iliac leg graft. Reposition the iliac leg
graft if necessary to ensure both internal iliac patency and a minimum
overlap of one full iliac leg stent (i.e., proximal stent of iliac leg graft,
maximum overlap of 1.5 stents) within the main body endovascular graft.
5. To deploy, hold the iliac leg graft in position with the gray positioner while
withdrawing the sheath. (Figs. 18 and 44) Ensure one stent overlap is
maintained.
6. Stop withdrawing the sheath as soon as the distal end of the iliac leg graft
is released.
7. Under fluoroscopy and after verification of the iliac leg graft position,
loosen the pin vise, and retract the inner cannula to dock the tapered
dilator to the gray positioner. Tighten pin vise. Maintain sheath position
while withdrawing gray positioner with secured inner cannula. (Fig. 45)
8. Re-check the position of the wire guides.
9. Perform molding balloon insertion and final angiogram as described in
Section 11.1.12, Molding Balloon Insertion.
14.2 Suprarenal Stent Deployment Troubleshooting
CAUTION: The following steps should be performed only if unable to
deploy the suprarenal stent as described in Section 11.1.7.
14.2.1 Main Body Proximal (Top) Deployment
1. If the suprarenal stent cannot be fully deployed by advancing the top cap
inner cannula, advance a molding balloon through the contralateral limb
of the main body and position it just superior to the bifurcation of the
stent graft.
2. To add support to the inner cannula, inflate the balloon to the full
diameter of the graft.
3. Loosen the pin vise. (Fig. 14)
4. Stabilize the gray positioner and balloon catheter, and advance the inner
cannula to deploy the suprarenal stent.
If the suprarenal stent is fully deployed:
5. Tighten the pin vise; deflate and withdraw the balloon.
6. Advance the contralateral wire guide into the thoracic aorta and return
to the appropriate step in the Instructions for Use to complete the
procedure.
If still unable to fully deploy the suprarenal stent:
5. Tighten the pin vise and deflate the balloon. While maintaining balloon
position, stabilize the gray positioner and withdraw the sheath to fully
deploy the ipsilateral limb.
6. Remove the safety lock from the ipsilateral limb trigger-wire release
mechanism.
7. Withdraw and remove the trigger-wire by sliding the ipsilateral limb
trigger-wire release mechanism off the handle, and remove via its slot
over the device inner cannula.
8. Loosen the pin vise (Fig. 22) and, while maintaining inner cannula
position, advance the gray positioner and sheath into the graft until the
tip of the gray positioner is approximately 2 cm inferior to the proximal
gold markers. (Fig. 46) The advanced gray positioner provides added
support to the inner cannula.
NOTE: Take care not to advance the graft during gray positioner and
sheath advancement.
NOTE: Ensure that the tip of the gray positioner is not advanced into the
top cap.
9. Lock the pin vise.
10. Verify position of the gold markers inferior to the renal arteries.
11. Reposition molding balloon so that it is seated against the bifurcation.
12. Inflate the balloon to the full diameter of the graft. (Fig. 37)
13. Loosen the pin vise.
14. Stabilize the gray positioner and balloon catheter, and advance the inner
cannula to deploy the suprarenal stent.
15. Tighten the pin vise.