Medtronic Valiant Navion Gebrauchsanweisung Seite 21

Caution: Do not place the proximal end of the covered stent graft beyond the distal edge of the left common carotid artery.
Caution: If the stent graft is deployed higher than the targeted landing zone, it is important to not deploy more than
2 covered stents before repositioning the stent graft.
Caution: Do not release the proximal end using the tip capture mechanism before the entire stent graft has been deployed,
as this may result in inaccurate deployment.
Caution: Ensure that the Valiant Navion devices are placed in a landing zone without evidence of circumferential
thrombus, intramural hematoma, ulceration, or aneurysmal involvement. Failure to do so may result in inadequate
exclusion or vessel damage, including perforation. Refer to Section 6.1 (Patient selection).
Note: A larger diameter stent graft may not fully appose to the vessel until 3 or more covered stents are exposed.
Note: If the system is tracked proximal to targeted landing zone and repositioned after 2 fabric covered stents are exposed,
it may be necessary to reestablish system position on the greater curve to avoid inadvertently displacing the stent graft
upon withdrawal of the graft cover.
Note: In the unlikely event of delivery system failure and concomitant partial stent graft deployment, refer to Section 10
(Troubleshooting techniques).
Note: The delivery system should be stabilized and remain stationary during stent graft deployment. Slight forward
pressure may be applied to maintain position.
1. FreeFlo configuration
2. CoveredSeal configuration
4. Verify position—Use angiography to verify the position of the stent graft in relation to the desired location. Use the proximal
RO markers to aid in visualizing the proximal end of the covered stent graft. If the stent graft was deployed higher than the
targeted landing zone, maintain the position of the slider handle and pull down on the entire delivery system until the
proximal RO markers indicating the top edge of the fabric are at the desired position. Restore system position on the
greater curve.
5. Deploy remainder of the stent graft—Continue withdrawing the graft cover. To rapidly deploy the stent graft, place
one hand firmly on the front grip and hold the system stationary. While maintaining support on the front grip, pull back the
trigger to engage the quick-release function of the slider handle. Pull the blue slider handle away from the front grip until the
RO marker band on the graft cover is beyond the distal stent. If excessive resistance is felt, release the trigger and rotate
the slider handle to complete deployment of the stent graft.
Figure 7. Deploying the proximal end of the stent graft
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Instructions for Use English 19