Ovation Prime Abdominal Stent Graft System; Manufacturer: TriVascular, Inc. 3910 Brickway Blvd. Santa Rosa, CA 95403 The TriVascular Ovation Prime Abdominal Stent Graft System is an endovascular device delivered via a small diameter catheter to treat abdominal aortic aneurysms (AAAs). The stent graft is designed to reline the diseased vasculature, providing an endovascular blood conduit for isolating the aneurysm from the high pressure flow of blood, thereby reducing the risk of rupture. The stent graft is a modular configuration comprised of an aortic body section, iliac limbs, and iliac extensions as required.
Enforcement
- Recall Number
- Z-1297-2014
- Event ID
- 67672
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Trivascular, Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- April 2, 2014
- Initiation Date
- February 27, 2014
- Classification Date
- March 26, 2014
- Termination Date
- April 11, 2014
- Address
- 3910 Brickway Blvd, N/A, Santa Rosa, CA, 95403, United States
Description
Ovation Prime Abdominal Stent Graft System; Manufacturer: TriVascular, Inc. 3910 Brickway Blvd. Santa Rosa, CA 95403 The TriVascular Ovation Prime Abdominal Stent Graft System is an endovascular device delivered via a small diameter catheter to treat abdominal aortic aneurysms (AAAs). The stent graft is designed to reline the diseased vasculature, providing an endovascular blood conduit for isolating the aneurysm from the high pressure flow of blood, thereby reducing the risk of rupture. The stent graft is a modular configuration comprised of an aortic body section, iliac limbs, and iliac extensions as required.
Communication to European physician users of the Ovation Prime Abdominal Stent Graft system to notify them of changes to Instructions for Use.
All codes
Worldwide Distribution including Austria, Belgium, Czech Republic, France, Germany, Greece, Hungary, Italy, Luxembourg, Norway, Poland, Spain, and Sweden.
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