MAUDE Adverse Event Report: ENDOLOGIX SANTA ROSA OVATION IX; MAIN BODY

Model Number	TV-AB3480-J
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/29/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The devices involved in this event will not be returned for evaluation and remain implanted in the patient.If additional information is obtained at a later time that is pertinent to this event, a follow-up report will then be submitted.Devices remain implanted in patient.
Event or Problem Description
The patient was initially treated for an abdominal aortic aneurysm (aaa) with the ovation ix abdominal aortic aneurysm stent.During the initial implant procedure, a type ia endoleak was observed.The physician elected to implant a palmaz stent and balloon, however, the endoleak was persistent.The patient was reportedly stable when leaving the operating room and the physician will continue to monitor the patient.As of date, there have been no additional patient sequelae reported.
Additional Manufacturer Narrative
Clinical assessment was completed based on the received medical records.The reported intraoperative and persistent type 1a endoleak at the conclusion of the initial procedure was unconfirmed due to a lack of the relevant medical information.Requests were made for medical imaging; however, there were none available per the hospital.Device, user, procedure or anatomy relatedness of this complaint could not be determined.The final patient status was reported being on surveillance till one month follow up.No evidence of the secondary endovascular procedure.The device remains implanted; therefore, no device evaluation was completed.The manufacturing lot evaluation confirmed all devices met specifications prior to release.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: MAIN BODY
• Manufacturer (Section D): ENDOLOGIX SANTA ROSA; 3910 brickway blvd; santa rosa CA 95403
• MDR Report Key: 9751697
• Report Number: 3008011247-2020-00031
• Device Sequence Number: 14096631
• Product Code: MIH
• UDI-Device Identifier: M701TVAB3480J1
• UDI-Public: +M701TVAB3480J1/$$3220806FS080119012
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P120006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/29/2020

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: 08/06/2022
• Device Model Number: TV-AB3480-J
• Device Catalogue Number: TV-AB3480-J
• Device Lot Number: FS080119-01
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/29/2020
• Supplement Date Received by Manufacturer: 01/29/2020
• Initial Report FDA Received Date: 02/25/2020
• Supplement Report FDA Received Date: 08/04/2020
• 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 IX ILIAC LIMB FS033017-28.; OVATION IX ILIAC LIMB FS091719-24.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 82 YR