MAUDE Adverse Event Report: ENDOLOGIX (TRIVASCULAR INC.) OVATION PRIME; MAIN BODY

Model Number	TV-AB2680-E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Aneurysm (1708); Failure of Implant (1924)
Date of Event	03/13/2018
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 prime abdominal stent graft system was implanted to treat an abdominal aortic aneurysm.The patient returned approximately 3 years post index procedure where growth of the aneurysm sac was observed.An angiogram was performed and the physician could not confirm if there was an endoleak, however, he placed a cuff to cover a suspicious area that was observed on the angiogram.Another ct was performed post re-intervention where a continued endoleak, potentially a type iiib, was observed.Physician elected to re-intervene a second time by relining with an afx graft.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 failure to exclude aneurysm at implant and subsequent persistent loss of seal one month post implant was found to be anatomy related due to the hostile neck anatomy.There were no procedure-related harms detected, and the patient was discharged home on the second post-operative day.It was noted that the patient was discharged with antiplatelet and anticoagulation therapy, which may have contributed to the persistent endoleak.A review of the device quality records shows that the device demonstrated compliance to established procedures and specifications at the time of manufacture.Codes: (b)(4).

• Brand Name: OVATION PRIME
• Common Device Name: MAIN BODY
• Manufacturer (Section D): ENDOLOGIX (TRIVASCULAR INC.); 3910 brickway blvd.; santa rosa CA 95403
• MDR Report Key: 7375970
• Report Number: 3008011247-2018-00058
• Device Sequence Number: 13470337
• Product Code: MIH
• UDI-Device Identifier: M701TVAB2680E1
• UDI-Public: +M701TVAB2680E1/$$3171210FS10231424W
• 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: 2015
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2018

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: 12/10/2017
• Device Model Number: TV-AB2680-E
• Device Catalogue Number: TV-AB2680-E
• Device Lot Number: FS102314-24
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/13/2018
• Supplement Date Received by Manufacturer: 03/13/2018
• Initial Report FDA Received Date: 03/27/2018
• Supplement Report FDA Received Date: 03/27/2018
• 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