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

Model Number	TV-IL1418120-J
Medical Device Problem Code	Occlusion Within Device (1423)
Health Effect - Clinical Code	Occlusion (1984)
Date of Event	10/19/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device remains implanted.
Event or Problem Description
An ovation ix abdominal stent graft system was implanted to treat an abdominal aortic aneurysm.Approximately 1.5 hours post-op, the post-operative ct showed evidence of compression of the iliac limb stent graft at the junction of the aortic body and iliac limb, with thrombosis of the iliac limb.A re-intervention was performed to place balloon expandable stents successfully restoring bloodflow.Following the re-intervention, the patient experienced paraplegia.As of the date of this report, there have been no additional patient sequelae reported and the patient will continue to be monitored.

• Brand Name: OVATION IX 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: 6110677
• Report Number: 3008011247-2016-00125
• Device Sequence Number: 19000846
• Product Code: MIH
• UDI-Device Identifier: M701TVIL1418120J1
• UDI-Public: +M701TVIL1418120J1/$$3190831FS03211651P
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 10/19/2016

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: 08/31/2019
• Device Model Number: TV-IL1418120-J
• Device Catalogue Number: TV-IL1418120-J
• Device Lot Number: FS032116-51
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/19/2016
• Initial Report FDA Received Date: 11/17/2016
• 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: BALLOON EXPANDABLE STENT (X2)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR