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

Model Number	TV-IL1428140-J
Medical Device Problem Code	Occlusion Within Device (1423)
Health Effect - Clinical Code	Stenosis (2263)
Date of Event	06/06/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device remains implanted.
Event or Problem Description
An ovation prime aortic body stent graft and ovation ix iliac limb stent grafts were implanted to treat an abdominal aortic aneurysm.The 2 month post-operative ct imaging showed the presence of compression/narrowing of the left iliac limb stent graft due to infrarenal angulation noted at the aortic body/ iliac limb stent graft overlap.There was evidence of thrombus formation; however, it was noted that the iliac limb remained patent.A thrombectomy re-intervention was performed followed by the placement of a bilateral balloon expandable stents within the iliac limbs extending up to the aortic body sealing rings successfully resolving the stenosis.As of the date of this report, there have been no additional patient sequelae reported.

• 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: 5771037
• Report Number: 3008011247-2016-00073
• Device Sequence Number: 538937
• Product Code: MIH
• UDI-Device Identifier: M701TVIL1428140J1
• UDI-Public: +M701TVIL1428140J1/$$3160623FS04231520M
• 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): 06/06/2016

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: 06/23/2016
• Device Model Number: TV-IL1428140-J
• Device Catalogue Number: TV-IL1428140-J
• Device Lot Number: FS042315-20
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2016
• Initial Report FDA Received Date: 07/05/2016
• 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