MAUDE Adverse Event Report: ENDOLOGIX (TRIVASCULAR INC.) OVATION IX; ILIAC LIMB

Model Number	TV-IL1414120-J
Medical Device Problem Codes	Occlusion Within Device (1423); Off-Label Use (1494)
Health Effect - Clinical Codes	Failure of Implant (1924); Occlusion (1984)
Date of Event	01/26/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Endologix will continue to investigate the reported event.The patient medical records and imaging studies will be requested for further evaluation by a clinical specialist.A final report will be submitted once the investigation of the reported event has concluded.
Event or Problem Description
An ovation ix iliac limb stent graft system was implanted to treat an abdominal aortic aneurysm.The patient returned approximately two months post-index procedure where physician observed a limb occlusion.The physician elected to re-intervene by placing four lifestream covered stents in the left limb and one stent at the proximal right limb to kiss at the ovation main body flow divider, successfully resolving the occlusion.As of the date of this report, there have been no additional patient sequelae reported.
Additional Manufacturer Narrative
Based on the clinical assessment for this event, the most likely cause of the occlusion within the device was found to be user related, due to the off-label aortic anatomy.The continued tobacco use and pre-existing outflow disease of the left lower extremity of the patient also likely contributed to the event.There were no procedure related harms identified.The patient was discharged home stable on the first post-operative day.A review of the device quality records shows that the device demonstrated compliance to established procedures and specifications at the time of manufacture.

• Brand Name: OVATION IX
• Common Device Name: ILIAC LIMB
• Manufacturer (Section D): ENDOLOGIX (TRIVASCULAR INC.); 3910 brickway blvd.; santa rosa CA 95403
• MDR Report Key: 7285673
• Report Number: 3008011247-2018-00026
• Device Sequence Number: 16587579
• Product Code: MIH
• UDI-Device Identifier: M701TVIL1414120J1
• UDI-Public: +M701TVIL1414120J1/$$3200906FS09011727O
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P120006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/26/2018

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: Health Professional
• Device Expiration Date: 09/06/2020
• Device Model Number: TV-IL1414120-J
• Device Catalogue Number: TV-IL1414120-J
• Device Lot Number: FS090117-27
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/26/2018
• Supplement Date Received by Manufacturer: 01/26/2018
• Initial Report FDA Received Date: 02/21/2018
• Supplement Report FDA Received Date: 05/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: OVATION IX ILIAC LIMB: TV-IL1414120-J; OVATION IX MAIN BODY: TV-AB2680-J
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR