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

Model Number	TV-IL1428100-J
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Stenosis (2263)
Date of Event	05/12/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device remains implanted.
Event or Problem Description
An afx bifurcated stent graft with ovation ix iliac limb stent grafts were implanted to treat an abdominal aortic aneurysm.During the index procedure, right hypogastric artery was inadvertently partially covered with the ovation ix iliac limb stent graft.The 30-day follow-up ct showed the right iliac limb stent graft encroached upon the right hypogastric artery with evidence of occlusion or stenosis noted.The physician elected to perform a re-intervention to place a stent in the right hypogastric artery to preserve blood flow, followed by the placement of an additional iliac limb.As of the date of this report, there have been no additional patient sequelae reported.

• Brand Name: OVATION IX ILIAC LIMB STENT GRAFT
• Common Device Name: ENDOVASCULAR GRAFT, ABDOMINAL AORTIC ANEURYSM
• Manufacturer (Section D): TRIVASCULAR, INC.; 3910 brickway blvd.; santa rosa CA 95403
• MDR Report Key: 5777436
• Report Number: 3008011247-2016-00072
• Device Sequence Number: 219885
• Product Code: MIH
• UDI-Device Identifier: M701TVIL1428100J1
• UDI-Public: +M701TVIL1428100J1/$$3161013FS03161531F
• 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): 05/12/2016

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: 10/13/2016
• Device Model Number: TV-IL1428100-J
• Device Catalogue Number: TV-IL1428100-J
• Device Lot Number: FS031615-31
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2016
• Initial Report FDA Received Date: 07/07/2016
• 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: Other