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

Model Number	TV-IL1412140-J
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	04/03/2017
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 9 month post-operative ct showed the presence of a type 1b endoleak at the right iliac.A re-intervention was performed to implant an ovation iliac limb extension extending the seal into the right common iliac artery, successfully resolving the endoleak.As of the date of this report, there have been no additional patient sequelae reported.
Additional Manufacturer Narrative
Based on the description of the event and provided medical records, clinical assessment confirmed the reported event of the type 1b endoleak from the right iliac limb and the secondary procedure.Additionally, clinical assessment identified a type ii endoleak at the ima from the 1 month post implant review, contrast pool behind collar from a lumbar artery superior to sealing ring from the 7 month post implant review, and persistent el2-ima, persistent contrast pool behind collar from the 9 month post implant; post secondary repair review.The most likely cause of the type ib endoleak was significant calcium in the rcia.The type ii endoleak was most likely due to the patent ima.The review of manufacturing lot confirmed all devices met specifications prior to release.No additional investigations of this reported complaint are planned.Endologix will continue to monitor this complaint and similar complaints in the event further investigation is needed.

• 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 95403
• MDR Report Key: 6542827
• Report Number: 3008011247-2017-00205
• Device Sequence Number: 18865480
• Product Code: MIH
• UDI-Device Identifier: M701TVIL1412140J1
• UDI-Public: +M701TVIL1412140J1/$$3190428FS10081549W
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2017

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?: Yes
• Operator of Device: Physician
• Device Expiration Date: 04/30/2019
• Device Model Number: TV-IL1412140-J
• Device Catalogue Number: TV-IL1412140-J
• Device Lot Number: FS100815-49
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/23/2017
• Supplement Date Received by Manufacturer: 05/22/2017
• Initial Report FDA Received Date: 05/03/2017
• Supplement Report FDA Received Date: 05/30/2019
• 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
• Patient Age: 70 YR