Medtronic Endurant Manual Del Usuario página 18

2011/DEC/22 at 7:46 p.m. Doc number: M716803B001 [multi23]
Caution: Do not retract the graft cover of the Endurant Delivery System until the system is accurately
placed within the vasculature and ready for deployment.
Caution: Never advance or retract equipment from the vasculature without the use of fluoroscopy.
9.6.1. Vascular Access
Following aseptic procedure, perform a vascular access at the femoral arteries. Place a guidewire in the
ipsilateral femoral artery and advance it above the renal arteries. From the contralateral side femoral artery,
place a second guidewire directed to the abdominal aorta. Over this second guidewire, place an
angiography catheter above the renal arteries. Consider taking an angiogram.
Note: There is a possibility that an additional incision might be necessary to access the common iliac
artery.
9.6.2. Preparation
Prior to insertion, it is advisable to view each delivery system under fluoroscopy to visualize the radiopaque
markers on the stent graft component. The radiopaque markers indicate the position of the proximal and
distal edges of the graft material and some additional guide markers on graft material. For a bifurcated
component turn the graft cover to align the radiopaque marker on the stub leg with the patient's
contralateral iliac artery. Flush the guidewire lumen with heparinized saline.
9.7. Delivery Procedure Endurant Stent Graft System
Medtronic Vascular recommends using an appropriate caliber introducer sheath to perform diagnostic
tests.
Caution: Do not remove the guidewire while the delivery system is in the patient.
Warning: NEVER ADVANCE THE OBTURATOR WITHOUT FIRST HAVING PLACED A GUIDEWIRE.
NEVER ADVANCE AN INTRODUCER SHEATH BEFORE THE OBTURATOR IS FULLY INSERTED.
Warning: TO PREVENT THROMBOTIC PROBLEMS, A SECOND BOLUS OF IV HEPARIN IS
RECOMMENDED BEFORE INSERTING THE DEVICE.
9.7.1. Introduction of Bifurcated Stent Graft Component
Wet the graft cover of the delivery system to activate the hydrophilic coating. Slowly insert the Endurant
Aortic Delivery System containing a bifurcated stent graft component. Advance over the guidewire so that
the proximal most stent and the radiopaque markers are visualized in the target proximal aortic neck. Refer
to Figure 8.
Inject contrast media into the abdominal aorta and mark the position of the target location, either on the
imaging screen or on the patient's body. Adjust the position of the bifurcated stent graft component such
that the top edge of the graft fabric is just below the lowest renal artery. The edge of the graft fabric is
0.5 to 1.0 mm above the top edge of the proximal radiopaque markers (1.0 to 1.5 mm above the center
of proximal radiopaque markers).
Note: If the top edge of the graft fabric is to be placed very close to the renal arteries, contrast media may
be injected to identify the location of the lower renal artery and verify the position before fully deploying
device. Once the proximal position has been identified, do not move the patient or imaging equipment.
The angiographic catheter can be removed prior to deployment. However, if the angiographic catheter is
not removed until after the deployment, ensure that the tip is straightened (pigtail catheter) with a guidewire
before removal so that the stent graft is not pulled down.
Caution: When aligning the position of an Endurant Stent Graft System Component, be sure the
fluoroscope is angled perpendicularly to the center line of the infrarenal aorta to avoid parallax or other
source of visualization error. Some cranial caudal angulation of the I-I tube may be necessary to achieve
this, especially if there is anterior angulation of the aneurysm neck.
Figure 8. Introduce the Endurant Aortic Delivery System
Note: Graphic representation not to scale
9.7.2. Confirm Position
Ensure that the distal portion of the contralateral stub leg is above the aortic bifurcation and within the
aneurysmal sac, and not within the iliac vessel. Rotate the handle until the radiopaque marker on the distal-
most stent of the contralateral stub leg is aligned with the contralateral iliac artery. In this orientation, the
cylindrical radiopaque marker on the distal most stent of the contralateral gate will be oriented to the side.
When attempting to rotate the system, if a tip response is not observed, do not continue to torque the
delivery system. Pull back the system and re-position until the intended position is achieved.
9.7.3. Deploying the Proximal End of Bifurcated Component
With one hand on the front grip, hold the Endurant Aortic Delivery System stationary. Next, slowly withdraw
the graft cover with the other hand by rotating the slider counter-clockwise (in the direction of the arrow
on the slider), until two to three of the covered stents have been fully deployed as depicted in Figure 9.
Use angiography to verify the position of the stent graft in relation to the renal arteries.
If needed, gently push the entire delivery system proximally or distally until the proximal end of the graft
material is even with the distal edge of the lowest renal artery.
Note: In the unlikely event of delivery system failure that results in partial stent graft deployment due to
graft cover severance, the "handle disassembly" technique may permit the successful deployment of the
stent graft. Refer to Section 9.8.
Caution: Do not rotate the graft cover during deployment.
Caution: If the graft cover is accidentally withdrawn, the stent graft component will prematurely deploy
and may be incorrectly positioned.
Warning: FAILURE TO PROPERLY ALIGN THE RADIOPAQUE MARKERS MAY RESULT IN
IMPROPER DEPLOYMENT OF THE STENT GRAFT COMPONENT.
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