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

Model Number	TV-IL1412160-J
Medical Device Problem Codes	Failure To Adhere Or Bond (1031); Leak/Splash (1354)
Health Effect - Clinical Codes	Aneurysm (1708); Failure of Implant (1924)
Date of Event	02/20/2018
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 10 months post index procedure with complaints of back pain.A ct was performed where physician observed a type ib endoleak due to growth of the right common iliac artery since initial implant.It was noted that the initial implant procedure was successful with no endoleaks.The patient was transferred to baylor st.Luke's in houston where physician there elected to perform a re-intervention by placing coils in the right hypogastric and extended the right iliac limb with an additional ovation limb.The re-intervention was successful and patient is reported as doing well.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 loss of seal was found to be anatomy related due to the pre-existing calcifications in the right common iliac artery.Procedure related harms could not be identified due to a lack of medical records surrounding the secondary procedure.The final patient disposition was reported to be in favorable condition and there have been 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.Codes: (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: 7357572
• Report Number: 3008011247-2018-00038
• Device Sequence Number: 11268621
• Product Code: MIH
• UDI-Device Identifier: M701TVIL1412160J1
• UDI-Public: +M701TVIL1412160J1/$$3190224FS01271628R
• 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): 02/20/2018

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: 02/24/2019
• Device Model Number: TV-IL1412160-J
• Device Catalogue Number: TV-IL1412160-J
• Device Lot Number: FS012716-28
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/20/2018
• Supplement Date Received by Manufacturer: 02/20/2018
• Initial Report FDA Received Date: 03/21/2018
• 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-IL1418140-J; OVATION IX MAIN BODY: TV-AB3480-J
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 88 YR