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

Model Number	TV-IL1418120-J
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Stenosis (2263)
Date of Event	12/22/2016
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.The patient presented 23 days post-operative with numbness in the right leg and a reduced palpable pulse.The post operative ct showed a stenosis of the right iliac limb stent graft with evidence of compression of the right iliac limb stent graft in the presence of significant aortic narrowing at the level of the native aortic bifurcation.A re-intervention is planned at a later date to place a balloon expandable stent within the compressed iliac limb stent graft.As of the date of this report, the re-intervention has not been scheduled and the patient will continue to be monitored.There have been no additional patient sequelae reported.

• Brand Name: OVATION IX ILIAC LIMB 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: 6314487
• Report Number: 3008011247-2017-00012
• Device Sequence Number: 543711
• Product Code: MIH
• UDI-Device Identifier: M701TVIL1418120J1
• UDI-Public: +M701TVIL1418120J1/$$3190616FS02051626T
• 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): 01/11/2017

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: 06/16/2019
• Device Model Number: TV-IL1418120-J
• Device Catalogue Number: TV-IL1418120-J
• Device Lot Number: FS020516-26
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/11/2017
• Initial Report FDA Received Date: 02/09/2017
• 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: Other
• Patient Age: 61 YR