Patient Counseling Information - Medtronic Valiant Navion Gebrauchsanweisung

Vessel diameter indication (mm)
Caution: Proper sizing of the Valiant Navion thoracic stent graft is the responsibility of the physician. This stent graft sizing
incorporates the recommended device oversizing for anatomical dimension and was based on in vitro test data. Additional
oversizing should not be incorporated.
Caution: Oversizing of the stent graft to the vessel by more than 10% may be unsafe in the presence of dissecting tissue or
intramural hematoma.
When multiple stent grafts are needed to exclude the target lesion, and the component junction or overlapping connection is not
supported by the nondiseased vessel (that is, it is in the aneurysm sac), the diameter of the inside component should be
oversized by 6 mm relative to the outside component. In the case when a 20 mm stent graft is used as an outside component,
the diameter of the inside component should be oversized by 5 mm relative to the outside component. If it is supported by the
vessel, the stent graft should be oversized relative to the supporting native vessel, as described in Table 6. In order to provide
the appropriate oversizing at a component junction, tapered configurations may need to be used.
The order of deployment when using multiple stent graft configurations may vary, depending on the diameter of the aorta
proximal to and distal to the lesion. Table 9 should be followed to determine the order of deployment when using multiple stent
graft configurations.
Caution: When treating acute dissections with multiple devices, deploy the proximal device first. Inadvertent pressurization of
the false lumen may result in retrograde dissection.
Note: If the vessel diameter and condition require variable proximal and distal diameter configurations, the smallest diameter
stent graft should be placed first, either at the proximal or distal end of the lesion.
Caution: The proximal end of a FreeFlo stent graft should never be placed inside the covered section of another stent graft.
Table 9. Order of deployment when using multiple stent graft component sections
Proximal aortic diameter = distal
aortic diameter
First section Proximal main section implanted at
implanted (pri- proximal end of lesion
mary section)
Second section Distal main section implanted with
implanted correct junction oversizing. Due to
(additional sec- taper configuration of distal main
tion) section, this fits a straight aorta cor-
rectly
Third section [Optional] additional sections implan-
implanted ted with correct oversizing at junction
(additional sec-
tion)

7. Patient counseling information

The physician should review the following information when counseling the patient about this endovascular device and
procedure:
■
Differences between endovascular repair and open surgical repair
Risks related to open surgical repair
■
Risks related to endovascular repair
■
■
Pros and cons of open surgical repair and endovascular repair
■
Potential advantages of endovascular repair using a minimally invasive approach
■ Possibility that subsequent endovascular or open surgical repair may be required
■
Regular follow-up, including stent graft imaging, should be performed. For more information, refer to Section 11 (Follow-up
imaging recommendations).
■ Symptoms of aortic vessel rupture
23-26
26-29
28-32
30-35
33-38
36-41
39-44
Proximal aortic diameter > distal
aortic diameter
Distal main section (or other configura-
tion if more appropriate) implanted at
distal end of lesion
Proximal main section implanted with
correct oversizing at junction with Distal
Main Section. Proximal telescoping of
devices fits this shape of aorta
[Optional] additional sections implanted
with correct oversizing at junction
Graft diameter (mm)
28
31
34
37
40
43
46
Proximal aortic diameter <
distal aortic diameter
Proximal main section
implanted at proximal end of
lesion
Distal main section implan-
ted with correct oversizing at
junction
[Optional] additional sections
implanted with correct over-
sizing at junction
Instructions for Use English 15