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

Model Number	TV-AB2980-E
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Endologix will continue to investigate the reported event.The patient medical records and imaging studies have been 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 (aaa).Approximately three (3) years post op, on an unknown date in (b)(6) 2018, the patient presented to the hospital with abdominal pain and a suspected type 1a endoleak.The physician treated the patient by implanting a non-endologix (cook medical) zfen graft attempting to resolve the type 1a endoleak.Approximately four (4) months post re-intervention, the patient presented to a scheduled visit with severe lifestyle limiting claudication and nonpalpable bilateral femoral pulses.Angiogram identified severe high grade stenosis 2cm above the flow divider.Ballooning was performed to increase blood flow.Reportedly, the event of stenosis was due to enfolding of the non-endologix (zfen) stent within the ovation prime rings and was not related to the endologix device.Patient had palpable femoral pulses post additional re-intervention.
Additional Manufacturer Narrative
Clinical assessment was completed based on the received medical records.The reported events of urgent presentation, type ia endoleak, severe lifestyle limiting claudication, non-endologix stent infolding requiring ballooning, and secondary endovascular procedure are unconfirmed due to lack of contrasted medical imaging and operative notes.The placement of fenestrated non-endologix stents in the celiac artery, superior mesenteric artery, bilateral renal arteries, and proximal aorta is confirmed.Device, user, procedure or anatomy relatedness of these events could not be determined.Procedure related harms for this complaint could not be determined.The final patient status was not reported.The manufacturing lot evaluation was unable to be performed as the lot number was unknown.The device remains implanted; therefore, no device evaluation was completed.No additional investigation of this reported event is planned; however, if additional information pertinent to the incident is obtained, a follow-up report will be submitted.Endologix will continue to monitor this complaint and similar complaints in the event further investigation is needed.

• 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: 8525438
• Report Number: 3008011247-2019-00062
• Device Sequence Number: 1928605
• Product Code: MIH
• UDI-Device Identifier: M701TVAB2980E1
• UDI-Public: +M701TVAB2980E1/$$3180618FS031015142
• 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: 2015
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2019

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: 06/18/2018
• Device Model Number: TV-AB2980-E
• Device Catalogue Number: TV-AB2980-E
• Device Lot Number: FS031015-14
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/20/2019
• Supplement Date Received by Manufacturer: 03/20/2019
• Initial Report FDA Received Date: 04/17/2019
• Supplement Report FDA Received Date: 07/02/2020
• 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 (LN FS050815-32).; OVATION IX ILIAC LIMB (LN FS052215-55).
• Outcome Attributed to Adverse Event: Required Intervention