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

Model Number	TV-EX121245-J
Medical Device Problem Codes	Occlusion Within Device (1423); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Occlusion (1984)
Date of Event	07/15/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device remains implanted.
Event or Problem Description
An afx abdominal stent graft system with an ovation ix iliac limb extension was implanted to treat an abdominal aortic aneurysm.Upon deployment of the iliac limb extension, the iliac limb extension was inadvertently deployed between the stent graft mainbody and the aortic wall, occluding the blood flow to the right common iliac artery.The patient was converted to aui with a fem-fem bypass to restore blood flow and the aneurysm was successfully excluded.As of the date of this report, there have been no additional patient sequelae reported.

• Brand Name: OVATION IX ILIAC LIMB EXTENSION
• Common Device Name: ENDOVASCULAR GRAFT, ABDOMINAL AORTIC ANEURYSM
• Manufacturer (Section D): TRIVASCULAR, INC.; 3910 brickway blvd.; santa rosa CA 95403
• MDR Report Key: 5874832
• Report Number: 3008011247-2016-00092
• Device Sequence Number: 1196186
• Product Code: MIH
• UDI-Device Identifier: M701TVEX121245J1
• UDI-Public: +M701TVEX121245J1/$$3190119FS01161624W
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 07/15/2016

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: 01/19/2019
• Device Model Number: TV-EX121245-J
• Device Catalogue Number: TV-EX121245-J
• Device Lot Number: FS011616-24
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2016
• Initial Report FDA Received Date: 08/14/2016
• 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