Medtronic Valiant Navion Gebrauchsanweisung Seite 20

9.6. Confirming stent graft position
1. Before deploying the Valiant Navion thoracic stent graft, confirm the proper position of the device using fluoroscopy.
2. When placing the stent graft, verify that the proximal RO markers are in the desired location (Figure 6). Placement of the
distal end is verified by ensuring that the distal markers are in the desired location. Additional stent grafts may be implanted
to extend the length of coverage and exclude the lesion. For additional information, refer to Section 9.11 (Implanting
additional configurations).
Note: The circumferential position of the RO markers will vary. The Valiant Navion thoracic stent graft is axisymmetric and does
not require rotational orientation to achieve the desired clinical results.
Note: To confirm stent graft position when implanting 2 or more Valiant Navion devices, the minimum overlap is achieved by
aligning the distal markers of the proximal graft with the mid-marker of the distal graft, except when using a distal stent graft
that is shorter than 90 mm. Refer to Section 9.11 (Implanting additional configurations).
Note: If using a stent graft that is shorter than 90 mm to extend proximal stent graft coverage, deploy the proximal graft
material edge of the stent graft no more than 10 mm proximal to the graft material edge of the adjacent stent graft. To extend
proximal landing zone coverage more than 10 mm, use a stent graft with a covered length of ≥90 mm. The most proximal stent
graft must meet the proximal landing zone requirements for either FreeFlo (≥20 mm) or CoveredSeal (≥25 mm).
Note: If using a stent graft that is shorter than 90 mm to extend distal stent graft coverage, deploy the distal graft material edge
of the stent graft no more than 10 mm distal to the graft material edge of the adjacent stent graft. To extend distal landing zone
coverage more than 10 mm, use a stent graft with a covered length of ≥90 mm. The most distal stent graft must meet the distal
landing zone requirement (≥20 mm for both FreeFlo and CoveredSeal). Refer to Section 6.1 (Patient selection).
Caution: In the presence of excessive calcification or thrombus formation, it is not recommended to position the device higher
and then reposition distally after partial stent graft deployment, due to increased risk of dislodging material.
Caution: Do not use stent grafts shorter than 90 mm at an unsupported joint or to connect 2 previously placed stent grafts.
Caution: Avoid or compensate for parallax or other sources of visualization error.
Caution: Do not grip the tip capture release handle while confirming the position of the delivery system.
9.7. Deploying the Valiant Navion thoracic stent graft
1. Ensure delivery system is along the greater curve in order to maintain stability during deployment.
2. Decreasing mean arterial blood pressure (MAP)—Upon confirming that the delivery system is positioned properly, it may
be appropriate to momentarily decrease the patient's MAP (at the discretion of the physician) to avoid inadvertently
displacing the Valiant Navion thoracic stent graft upon withdrawal of the graft cover.
3. Deploying the proximal end—First, hold the delivery system stationary with one hand on the gray front grip. Then, slowly
withdraw the graft cover with the other hand by rotating the slider handle in the direction of the arrow (counterclockwise). It
may take multiple rotations before the graft cover separates from the tip, visualized by movement of the RO marker band.
The proximal end of the stent graft will be constrained by the tip capture mechanism. Withdraw the graft cover until at least
2 fabric-covered stents are exposed.
Caution: For stent grafts that are shorter than 90 mm, it is important not to deploy more than one covered stent before
repositioning the stent graft. Further deployment of the graft can impair the ability to move the graft to the desired landing
zone.
18 Instructions for Use
Figure 6. Confirming stent graft position
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