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

Model Number	TV-IL1418120-J
Medical Device Problem Codes	Material Puncture/Hole (1504); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/13/2019
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 implanted with the ovation ix abdominal aortic stent graft system.Approximately eight (8)-months post-op the patient presented on an unknown date for a routine follow-up.A type iiib endoleak was detected by angiogram.The physician elected to treat the patient; implanting an additional ovation ix limb.The final angiogram confirmed the endoleak was resolved.The patient will continue to be monitored.
Additional Manufacturer Narrative
Clinical assessment was completed based on the received medical records.The reported type iiib endoleak was refuted, rather there was evidence of a type ib endoleak at the left common iliac artery.The type ib endoleak is most likely user related due to the off label left iliac anatomy of 31.8mm (ifu states iliac anatomy between 8-25mm).Additionally, the left common iliac anatomy limb landed in the aneurysmal iliac anatomy.The procedure related harms for this event could not be determined.The final patient status was reported being stable post the secondary endovascular procedure and will be monitored.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.
Event or Problem Description
The patient was initially implanted with the ovation ix abdominal aortic stent graft system.Approximately eight (8)-months post-op the patient presented on an unknown date for a routine follow-up.A type iiib endoleak was detected by angiogram.The physician elected to treat the patient; implanting an additional ovation ix limb.The final angiogram confirmed the endoleak was resolved.The patient will continue to be monitored.Subsequent to the initial report, clinical assessment refuted the reported type iiib endoleak; rather, there was evidence of a type ib endoleak at the left common iliac artery.

• Brand Name: OVATION IX
• Common Device Name: ILIAC LIMB
• Manufacturer (Section D): ENDOLOGIX (TRIVASCULAR); 3910 brickway blvd; santa rosa CA 95403
• MDR Report Key: 8778589
• Report Number: 3008011247-2019-00109
• Device Sequence Number: 19492704
• Product Code: MIH
• UDI-Device Identifier: M701TVIL1418120J1
• UDI-Public: +M701TVIL1418120J1/$$3200109FS08091637U
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2019

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: 01/09/2020
• Device Model Number: TV-IL1418120-J
• Device Catalogue Number: TV-IL1418120-J
• Device Lot Number: FS080916-37
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/13/2019
• Supplement Date Received by Manufacturer: 06/13/2019
• Initial Report FDA Received Date: 07/10/2019
• Supplement Report FDA Received Date: 07/23/2020
• 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.; OVATION IX ILIAC LIMB.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 86 YR