MAUDE Adverse Event Report: ENDOLOGIX SANTA ROSA OVATION IX; ILIAC LIMB

Model Number	TV-IL1418120-J
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Failure of Implant (1924)
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.
Event or Problem Description
The patient was initially treated for an abdominal aortic aneurysm (aaa) with the ovation ix abdominal aortic aneurysm stent.Approximately one (1) year post initial procedure, the patient presented with the right iliac limb slipped out of the iliac and resting in the aorta with no endoleak detected.The physician plans to reline with an additional iliac limb device and 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 implant movement was unconfirmed due to a lack of relevant medical records and imaging.Requests were made for medical images; however, there was no response received from the hospitals.Device, user, procedure or anatomy relatedness of this event could not be determined.The final patient status was reported to be under surveillance pending a 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: ILIAC LIMB
• Manufacturer (Section D): ENDOLOGIX SANTA ROSA; 3910 brickway blvd; santa rosa CA 95403
• MDR Report Key: 9814256
• Report Number: 3008011247-2020-00039
• Device Sequence Number: 16586195
• Product Code: MIH
• UDI-Device Identifier: M701TVIL1418120J1
• UDI-Public: +M701TVIL1418120J1/$$3210525FS05141843P
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2020

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: 05/25/2021
• Device Model Number: TV-IL1418120-J
• Device Catalogue Number: TV-IL1418120-J
• Device Lot Number: FS051418-43
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/12/2020
• Supplement Date Received by Manufacturer: 02/12/2020
• Initial Report FDA Received Date: 03/10/2020
• 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 IX ILIAC LIMB FS092518-23.; OVATION IX MAIN BODY FS072718-35.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 68 YR