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

Model Number	TV-IL1418100-J
Medical Device Problem Codes	Occlusion Within Device (1423); Improper or Incorrect Procedure or Method (2017); Malposition of Device (2616)
Health Effect - Clinical Code	Occlusion (1984)
Date of Event	01/18/2017
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 5 month post-operative ct imaging showed the presence of an occlusion of the right iliac limb stent graft due to the malposition of the iliac limb stent grafts within the leg of the aortic body stent graft in combination with the presence of significant infrarenal aortic angulation.A re-intervention is planned at a later date to treat the occluded limb.As of the date of this report, there have been no additional patient sequelae reported and the patient will continue to be monitored.
Additional Manufacturer Narrative
Based on the clinical assessment for this event, the reported loss of seal was determined to be unknown/undetermined due to a lack of a post operative ct.The exact position of the proximal sealing could not be confirmed but it appears to be in an area with calcifications below the intended landing zone, which likely contributed to the type ia endoleak.There were no adjunctive procedures were done at the time of implant to resolve the endoleak.There were no off-lable or cautionary product use conditions found.A review of the device quality records shows that the device demonstrated compliance to established procedures and specifications at the time of manufacture.(b)(4).

• Brand Name: OVATION IX AORTIC BODY 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: 6363012
• Report Number: 3008011247-2017-00024
• Device Sequence Number: 799107
• Product Code: MIH
• UDI-Device Identifier: M701TVIL1418100J1
• UDI-Public: +M701TVIL1418100J1/$$3190616FS01191644V
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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,Followup
• Report Date (Section B): 01/30/2017

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-IL1418100-J
• Device Catalogue Number: TV-IL1418100-J
• Device Lot Number: FS011916-44
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/30/2017
• Supplement Date Received by Manufacturer: 01/30/2017
• Initial Report FDA Received Date: 02/27/2017
• Supplement Report FDA Received Date: 09/29/2017
• 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: 89 YR