Medtronic Valiant Navion Gebrauchsanweisung Seite 24

1. Continue to hold the delivery system with one hand on the front grip and the other hand on the slider.
2. Pull back the trigger and hold the slider handle stationary while bringing the front grip towards the slider handle (Figure 11).
Use continual fluoroscopy and watch the proximal end of the Valiant Navion thoracic stent graft while slowly pulling back
the tapered tip into the graft cover of the delivery system.
Caution: If the delivery system catches on the stent graft during removal, it may be necessary to carefully advance the
delivery system until the capture fitting starts to move. Then retract the guidewire to assume a more centralized position in
the aorta before repeating steps for removing the delivery system.
3. Push the tip capture release handle forward so that the capture fitting moves toward the tapered tip. Monitor the movement
of the capture fitting using fluoroscopy.
Caution: Do not complete step 3 before step 2. Doing so may cause the tip capture mechanism to get caught on the
proximal stents.
4. Gently remove the delivery system, using fluoroscopy to ensure that the stent graft does not move during the withdrawal.
1. FreeFlo configuration
2. CoveredSeal configuration
9.10. Smoothing stent graft fabric and modeling the stent graft (optional)
The Reliant stent graft balloon catheter (available separately) can be used to remove wrinkles and folds from the graft material
and to assist in implanting the stent graft by modeling the covered stents. Refer to the Instructions for Use supplied with the
Reliant stent graft balloon catheter for more information. Use the balloon catheter to model the proximal and distal seal zones
and to improve suboptimal expansion of the self-expanding stent graft configurations.
Caution: Never use a balloon when treating a dissection.
Caution: Do not use the Reliant stent graft balloon catheter in patients with a history of aortic dissection disease. Do not
overinflate the balloon.
Caution: When expanding a vascular prosthesis using the Reliant stent graft balloon catheter, there is an increased risk of
vessel injury or rupture and patient death if the balloon's proximal and distal RO markers are not completely within the covered
(graft fabric) portion of the prosthesis.
Note: Use caution when inflating the balloon, especially with calcified, tortuous, stenotic, or otherwise diseased vessels. Inflate
slowly. It is recommended that a backup balloon be available.
Note: The Reliant stent graft balloon catheter is recommended for use with the Valiant Navion thoracic stent graft system. No
data are available for the use of other balloon catheters in remodeling stent grafts.
9.11. Implanting additional configurations
If 2 or more Valiant Navion thoracic stent graft configurations are required to exclude the lesion, follow the steps below. Refer
to Table 9 for order of deployment.
Caution: The proximal end of a FreeFlo stent graft should never be placed inside the fabric-covered section of another graft as
doing so may result in abrasion of the fabric by the bare stent, resulting in graft material holes or broken sutures.
Caution: Failure to provide sufficient overlap may result in the separation of stent graft components.
Caution: Do not use stent grafts shorter than 90 mm at an unsupported joint or to connect 2 previously placed stent grafts.
22 Instructions for Use
Figure 11. Removing the delivery system
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