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

Model Number	TV-AB2680-E
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Stenosis (2263)
Date of Event	01/12/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Remains implanted.
Event or Problem Description
An ovation prime abdominal stent graft system was implanted to treat an abdominal aortic aneurysm.The patient presented 6 months post-op with an aortic body stenosis in the presence of thrombus in the seal zone and significant aortic angulation.A re-intervention was performed in which the seal zone was ballooned and two (2) balloon expandable stents were implanted to successfully resolve the stenosis.As of the date of this report, there have been no additional patient sequelae reported.

• Brand Name: OVATION PRIME 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: 5435579
• Report Number: 3008011247-2016-00012
• Device Sequence Number: 530267
• Product Code: MIH
• UDI-Device Identifier: M701TVAB2680E1
• UDI-Public: +M701TVAB2680E1/$$3180121FS12111416X
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P120006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/15/2016

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: 01/21/2018
• Device Model Number: TV-AB2680-E
• Device Catalogue Number: TV-AB2680-E
• Device Lot Number: FS121114-16
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2016
• Initial Report FDA Received Date: 02/12/2016
• 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: Congenital Anomaly; Required Intervention
• Patient Age: 68 YR