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

Model Number	TV-AB3480-E
Medical Device Problem Codes	Contamination (1120); Off-Label Use (1494); Malposition of Device (2616)
Health Effect - Clinical Codes	Aneurysm (1708); Bacterial Infection (1735); Rupture (2208)
Date of Event	05/02/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device remains implanted.
Event or Problem Description
An ovation prime abdominal stent graft system was implanted to treat an abdominal aortic aneurysm.It was noted that the patient was outside the indications for use and the physician elected to proceed with the implant procedure by placing the aortic body stent graft higher than recommended with bilateral balloon expandable stents in the renal arteries to maintain blood flow.The patient presented 1 month index with a potential rupture of the aorta.The 1 month post-operative ct showed evidence of a type ia endoleak, and indications of a possible infection (aorto-duodenal fistula).The patient was administered intravenous antibiotics and underwent a surgical conversion in which the aneurysm sac was opened, the stent graft was left in place, antibiotics were introduced into the aneurysm sac, and the aorta was sewn closed over the stent graft.Bio glue was used to resolve the small type ia endoleak.Based on a follow-up communication received from the site, cultures results were reported as staphylococcus captis and peptostreptococcus species.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: 5692771
• Report Number: 3008011247-2016-00055
• Device Sequence Number: 190143
• Product Code: MIH
• UDI-Device Identifier: M701TVAB3480E1
• UDI-Public: +M701TVAB3480E1/$$3180312FS01191542/
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P120006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/02/2016

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: 03/12/2018
• Device Model Number: TV-AB3480-E
• Device Catalogue Number: TV-AB3480-E
• Device Lot Number: FS011915-42
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/02/2016
• Initial Report FDA Received Date: 06/01/2016
• 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: 81 YR