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

Model Number	TV-IL1410140-J
Medical Device Problem Code	Occlusion Within Device (1423)
Health Effect - Clinical Codes	Failure of Implant (1924); Occlusion (1984)
Date of Event	09/07/2017
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 abdominal stent graft system was implanted to treat an abdominal aortic aneurysm.Approximately seven months post-op, patient returned with reported left limb occlusion.The physician elected to perform an open thrombectomy with non-endologix devices.The clot was removed and sent for testing for possible atrial septic defect.The patient was reported as stable post-procedure.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 reported limb occlusion was found to be unknown/undetermined due to the lack of relevant medical information surrounding the event.The reported left common femoral artery endarterectomy and patch angioplasty, a possible clamp injury, or an embolism from the heart due to an atrial septal defect likely contributed to the event.Unable to determine procedure-related, anatomy-related, and user-related issues, or cautionary product use conditions.This was off-label due to concomitant use with products outside the instructions for use.The final patient disposition was reported as stable with no additional patient sequelae reported.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
• Common Device Name: ILIAC LIMB
• Manufacturer (Section D): ENDOLOGIX (TRIVASCULAR INC.); 3910 brickway blvd.; santa rosa CA 95403
• MDR Report Key: 6926534
• Report Number: 3008011247-2017-00060
• Device Sequence Number: 19128065
• Product Code: MIH
• UDI-Device Identifier: M701TVIL1410140J1
• UDI-Public: +M701TVIL1410140J1/$$3190210FS06301523B
• 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: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/07/2017

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: Health Professional
• Device Expiration Date: 02/10/2019
• Device Model Number: TV-IL1410140-J
• Device Catalogue Number: TV-IL1410140-J
• Device Lot Number: FS063015-23
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/07/2017
• Supplement Date Received by Manufacturer: 09/07/2017
• Initial Report FDA Received Date: 10/07/2017
• Supplement Report FDA Received Date: 12/06/2017
• 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: Required Intervention
• Patient Age: 60 YR