Recall Z-0125-2015 ยท MIH System, Endovascular Graft, Aortic Aneurysm Treatment
Trivascular, Inc
Ovation Prime Abdominal Stent Graft System - 29mm Aortic Body stent grafts. The TriVascular Ovation Prime Abdominal Stent Graft System is a low-profile endovascular device delivered via catheter to treat descending abdominal aortic aneurysms (AAAs).
| Date | Nov 3, 2014 (initiated Sep 20, 2014) |
| Status | Terminated |
| Reason | TriVascular has identified select lots of Ovation Prime 29mm Aortic Body stent grafts that may be associated with rapid emptying of the fill polymer syringe when it is connected to the Autoinjector during the fill polymer injection step of the primary implant procedure. |
| Root cause | Under Investigation by firm |
| Action | Urgent Field Safety Notice letter was sent to all consignees on 9/19/14 via trackable mail system. Users are notified that TriVascular has identified select lots of Ovation Prime 29mm Aortic Body stent grafts that may be associated with rapid emptying of the fill polymer syringe when it is connected to the Autoinjector during the fill polymer injection step of the primary implant procedure. |
| Quantity | 0 Devices |
| Distribution | International Distribution Only -- Canada, Turkey, Austria, Ireland, Belgium, Italy, Switzerland, Spain, France, and Cyprus. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.