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

Model Number	TV-IL1414160-J
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	08/22/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Remains implanted.
Event or Problem Description
An afx stent graft system with ovation ix iliac limbs was implanted to treat an abdominal aortic aneurysm.The final angiogram showed the presence of a type iiia endoleak at the overlap of the afx main body and the ovation ix iliac limb stent graft.A re-intervention was performed to place a balloon expandable stent and an additional afx stent graft to re-line the stent graft successfully resolving the endoleak.As of the date of this report, 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: 5980708
• Report Number: 3008011247-2016-00111
• Device Sequence Number: 671565
• Product Code: MIH
• UDI-Device Identifier: M701TVIL1414160J1
• UDI-Public: +M701TVIL1414160J1/$$3190324FS02081605P
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 08/22/2016

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: 03/24/2019
• Device Model Number: TV-IL1414160-J
• Device Catalogue Number: TV-IL1414160-J
• Device Lot Number: FS020816-05
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2016
• Initial Report FDA Received Date: 09/27/2016
• 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: AFX STENT GRAFT; PALMAZ STENT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 84 YR