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

Model Number	TV-IL1418140-J
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Occlusion (1984)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lot history records related to the subject device referenced in this complaint record were reviewed for potential contributing factors for the failure mode(s) described in this event.A review of the device quality records showed that the device(s) demonstrated compliance to established procedures and specifications at the time of manufacture.
Event or Problem Description
The patient was initially treated for an abdominal aortic aneurysm (aaa) with the ovation ix abdominal stent graft system.Approximately two (2) years post initial procedure, a limb occlusion was identified on unknown date.The patient was treated; lysed and relined with vbx (non-endologix) on an unknown date and reported as doing well.
Additional Manufacturer Narrative
Clinical assessment was completed based on the received medical records.The reported total occlusion of both ovation stents just below the renal arteries was confirmed.Device, user, procedure or anatomy relatedness of this event could not be determined.The procedure related harm identified was a prolonged hospitalization following the secondary endovascular procedure.Additionally, it was reported the patient had a previous thoracic aneurysm repair prior to the index evar procedure (cautionary product use condition).The final patient status was discharged on the ninth post-operative day to a rehabilitation unit due to a debilitated state.The manufacturing lot evaluation confirmed all devices met specifications prior to release.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 IX
• Common Device Name: ILIAC LIMB
• Manufacturer (Section D): ENDOLOGIX (TRIVASCULAR); 3910 brickway blvd; santa rosa CA 95403
• MDR Report Key: 9119187
• Report Number: 3008011247-2019-00147
• Device Sequence Number: 2113197
• Product Code: MIH
• UDI-Device Identifier: M701TVIL1418140J1
• UDI-Public: +M701TVIL1418140J1/$$3200105FS08051610F
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2019

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: 01/31/2020
• Device Model Number: TV-IL1418140-J
• Device Catalogue Number: TV-IL1418140-J
• Device Lot Number: FS080516-10
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/27/2019
• Supplement Date Received by Manufacturer: 08/27/2019
• Initial Report FDA Received Date: 09/25/2019
• Supplement Report FDA Received Date: 08/05/2020
• 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 CUSTOM SEAL FILL POLYMER.; OVATION IX AORTIC MAIN BODY.; OVATION IX ILIAC LIMB.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR