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

Model Number	TV-IL1414160-J
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Occlusion (1984); Pain (1994)
Date of Event	10/30/2019
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 four (4) months post-op, the patient presented emergently with a complaint of leg pain.A right limb and right femoral occlusion were detected with possible proximal migration of the limb.A decision was made to treat the patient with a 14x100 ovation ix iliac limb and thrombectomy which successfully resolved the occlusion.The patient was discharged post-op day 2.The patient is reported as doing well and healthy and will continue to be monitored.
Additional Manufacturer Narrative
The manufacturing lot evaluation confirmed all devices met specifications prior to release.The device was not returned therefore no evaluation was completed.At the completion of the clinical assessment, the urgent presentation with leg pain, with occluded right limb and femoral artery, secondary endovascular procedure event is confirmed only from the discharge summary.The proximal migration of the limb extension event is unconfirmed.The device, user, procedure, procedure-related harms, or anatomy relatedness of this event could not be determined with the medical records / images available for review.The final patient status was reported as being stable.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: 9359178
• Report Number: 3008011247-2019-00172
• Device Sequence Number: 13992859
• Product Code: MIH
• UDI-Device Identifier: M701TVIL1414160J1
• UDI-Public: +M701TVIL1414160J1/$$3211102FS10311853D
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: P120006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2019

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: 11/02/2021
• Device Model Number: TV-IL1414160-J
• Device Catalogue Number: TV-IL1414160-J
• Device Lot Number: FS103118-53
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/30/2019
• Supplement Date Received by Manufacturer: 10/30/2019
• Initial Report FDA Received Date: 11/21/2019
• Supplement Report FDA Received Date: 08/10/2020
• 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 (2).
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR