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

Model Number	TV-AB3480-J
Medical Device Problem Code	Occlusion Within Device (1423)
Health Effect - Clinical Codes	Failure of Implant (1924); Ischemia (1942); Occlusion (1984); Thrombosis (2100)
Date of Event	02/18/2018
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 was implanted to treat an abdominal aortic aneurysm.The patient presented emergently with a cold right foot.There was no diagnostic procedure done and the physician elected to perform a fem-fem bypass, successfully restoring blood flow to the right foot.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 inadequate stent graft patency was found to be unknown/undetermined due to the lack of medical records and imaging surrounding the event.Procedure related harms and the final patient disposition could not be determined as well, however, there have been no further 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.Codes: (b)(4).

• Brand Name: OVATION IX
• Common Device Name: MAIN BODY
• Manufacturer (Section D): ENDOLOGIX (TRIVASCULAR INC.); 3910 brickway blvd.; santa rosa CA 95403
• MDR Report Key: 7334639
• Report Number: 3008011247-2018-00036
• Device Sequence Number: 16244775
• Product Code: MIH
• UDI-Device Identifier: M701TVIL1410140J1
• UDI-Public: +M701TVIL1410140J1/$$3190309FS07061549W
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P120006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/18/2018

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: 09/26/2020
• Device Model Number: TV-AB3480-J
• Device Catalogue Number: TV-IL1410140-J
• Device Lot Number: FS090117-36
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/18/2018
• Supplement Date Received by Manufacturer: 02/18/2018
• Initial Report FDA Received Date: 03/13/2018
• Supplement Report FDA Received Date: 05/24/2018
• 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-IL1410160-J; OVATION IX ILIAC LIMB: TV-IL1422160-J; OVATION IX MAIN BODY: TV-AB3480-J
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR