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

Model Number	TV-AB2080-E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	12/02/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
An ovation prime abdominal stent graft system was implanted to treat an abdominal aortic aneurysm.The 1 year post-operative ct showed the presence of inflammation of the aorta with possible infection and aneurysm enlargement.The patient is reported to have previously underwent hernia repair several weeks before.The physician elected to explant the device; and cultures were taken intraoperatively during the explant procedure and the results reported as gram positive cocci.The procedure time is reported prolonged with units of blood provided.The patient was intubated and transferred to the icu for recovery.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: 6217009
• Report Number: 3008011247-2016-00140
• Device Sequence Number: 13559406
• Product Code: MIH
• UDI-Device Identifier: M701TVAB2080E1
• UDI-Public: +M701TVAB2080E1/$$3180515FS02271506/
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 12/02/2016

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: 05/15/2018
• Device Model Number: TV-AB2080-E
• Device Catalogue Number: TV-AB2080-E
• Device Lot Number: FS022715-06
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/02/2016
• Initial Report FDA Received Date: 01/01/2017
• 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: SURGICAL GRAFT
• Outcome Attributed to Adverse Event: Other