Ovation TriVascular, Instructions For Use Manual

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10
•
The long-term safety and effectiveness of endovascular repair has not been
established;
•
The importance of life-long, regular follow up to assess patient’s health
status and the stent graft performance;
•
Subsequent endovascular or open surgical repair of the aneurysm may be
required;
•
Signs to seek prompt medical attention (including limb occlusion, aneurysm
enlargement, or rupture).
8. How Supplied
The Ovation Abdominal Stent Graft System is comprised of the aortic body stent
graft/ delivery system, the iliac limbs and extensions stent graft/ delivery system, the
fill polymer kit, and the autoinjector.
The stent grafts are available in the following sizes and configurations.
Table 2.
Ovation Aortic Body Stent Graft sizes
Stent Graft
Proximal
Diameter
Catheter
Working
Length
Delivery
System Outer
Profile
Covered Stent
Graft Length
20 mm 57 cm 14 F 80 mm
23 mm
26 mm
29 mm
34 mm 15 F
Table 3.
Ovation Iliac Limb sizes
Stent Graft
Proximal
Diameter
Stent Graft
Distal
Diameter
Catheter
Working
Length
Delivery
System
Outer
Profile
Covered
Stent Graft
Length
14 mm 10 mm 53 cm 13 F 80 mm
10 mm 100 mm
10 mm 120 mm
10 mm 140 mm
12 mm 80 mm
12 mm 100 mm
12 mm 120 mm
12 mm 140 mm
14 mm 80 mm
14 mm 100 mm
14 mm 120 mm
14 mm 140 mm
16 mm 14 F 80 mm
16 mm 100 mm
16 mm 120 mm
16 mm 140 mm