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

Model Number	TV-AB2980-E
Medical Device Problem Codes	Malposition of Device (2616); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	12/16/2015
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 final angiogram showed the presence of an unresolved type ia endoleak due to the aortic body stent graft sealing rings being located in an aortic diameter outside the treatment range for the implanted stent graft.A re-intervention was performed 5 days post-op to place an aortic cuff at the level of the sealing rings which successfully resolved the type ia endoleak.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: 5365629
• Report Number: 3008011247-2016-00004
• Device Sequence Number: 55886
• Product Code: MIH
• UDI-Device Identifier: M701TVAB2980E1
• UDI-Public: +M701TVAB2980E1/$$3180701FS041415151
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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
• Report Date (Section B): 12/16/2015

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: 07/01/2018
• Device Model Number: TV-AB2980-E
• Device Catalogue Number: TV-AB2980-E
• Device Lot Number: FS041415-15
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/13/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 28MM AORTIC CUFF
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 86 YR