MAUDE Adverse Event Report: TRIVASCULAR, INC. OVATION ABDOMINAL STENT GRAFT SYSTEM; ENDOVASCULAR GRAFT, ABDOMINAL AORTIC ANEURYSM

Model Number	TV-IL1412120-B
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Stenosis (2263)
Date of Event	04/06/2012
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device remains implanted.
Event or Problem Description
An ovation abdominal stent graft system was implanted to treat an abdominal aortic aneurysm.The six month follow-up showed evidence of a stenosis of the left iliac limb and a potential type ii and/or type ib endoleak also on the left side.The left limb stenosis was reported to have been resolved without re-intervention.As of the date of this report, there have been no additional sequelae reported and the patient will continue to be monitored.

• Brand Name: OVATION ABDOMINAL STENT GRAFT SYSTEM
• Common Device Name: ENDOVASCULAR GRAFT, ABDOMINAL AORTIC ANEURYSM
• Manufacturer (Section D): TRIVASCULAR, INC.; 3910 brickway blvd.; santa rosa CA 95403
• MDR Report Key: 5543526
• Report Number: 3008011247-2016-00031
• Device Sequence Number: 16321405
• Product Code: MIH
• UDI-Device Identifier: M701TVIL1428140J1
• UDI-Public: +M701TVIL1428140J1/$$3160320FS01301540D
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P120006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Physician
• Device Expiration Date: 07/07/2014
• Device Model Number: TV-IL1412120-B
• Device Catalogue Number: TV-IL1412120-B
• Device Lot Number: FS031611-44
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2016
• Initial Report FDA Received Date: 04/03/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 88 YR