Medtronic Valiant Navion Gebrauchsanweisung Seite 25

Note: In vitro durability (fatigue) testing suggests that the long-term durability of the device may be compromised in conditions
with excessive device oversizing or deformation associated with cardiac and respiratory cycles. Wire fractures may have
unknown clinical consequences, which may include, but are not limited to, device migration, vessel perforation, loss of
aneurysm exclusion, false lumen enlargement, or death.
1. Refer to Section 9.3 (Preparation of the Valiant Navion thoracic stent graft system).
2. Refer to Section 9.4 (Introducing the delivery system). Advancement of the delivery system within the previously implanted
stent graft must be carefully monitored under fluoroscopy to ensure that the implanted stent graft does not move.
3. Refer to Section 9.5 (Positioning the delivery system).
4. Refer to Section 9.6 (Confirming stent graft position). Radiographically verify that the distal marker on the proximal graft
aligns with the mid-marker (between the third and fourth covered stents) on the distal graft to achieve the minimum overlap
distance, except when using a stent graft that is shorter than 90 mm. Refer to Figure 6, Figure 12, and Figure 13. Also,
verify that the markers on the additional stent graft indicate that the proximal and distal ends of the covered stent graft are
at the desired locations.
5. 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 landing zone requirements for either FreeFlo (≥20 mm) or CoveredSeal (≥25 mm).
6. 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). Refer to Section 6.1 (Patient selection).
7. Refer to Section 9.7 (Deploying the Valiant Navion thoracic stent graft).
8. Refer to Section 9.8 (Deploying tip capture mechanism).
9. Refer to Section 9.9 (Removing the delivery system).
10. Refer to Section 9.10 (Smoothing stent graft fabric and modeling the stent graft).
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Figure 12. Alignment of additional sections (first graft placed proximally)
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Instructions for Use English 23