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

Model Number	TV-AB2980-J
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/25/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device involved in this event will not be returned for evaluation as it remains implanted in the patient.Patient medical records and imaging studies will be requested for further evaluation by the clinical specialist.If additional information pertinent to the incident is obtained, a follow-up report will be submitted.Device remains implanted.
Event or Problem Description
The patient was initially implanted with the ovation ix abdominal stent graft system to treat an abdominal aortic aneurysm (aaa).Approximately two and half (2.5) years post initial procedure, the patient presented with an endoleak of indeterminate origin (suspected type 2).The patient is currently being monitored.Note: this patient had a previous report of a type 2 endoleak (non device related failure) in (b)(6) of 2018.
Additional Manufacturer Narrative
Clinical assessment of the reported event was unable to be completed due to a lack of receipt of relevant medical records and/or imaging.Only a discharge summary was received with little relevant information to this case.Requests for medical images were made; however, no response was received from the hospital.As such, event determination, off label conditions, related patient harms and patient disposition could not be assessed.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: MAIN BODY
• Manufacturer (Section D): ENDOLOGIX SANTA ROSA; 3910 brickway blvd; santa rosa CA 95403
• MDR Report Key: 9513449
• Report Number: 3008011247-2019-00183
• Device Sequence Number: 1410089
• Product Code: MIH
• UDI-Device Identifier: M701TVAB2980J1
• UDI-Public: +M701TVAB2980J1/$$3200118FS120916302
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/25/2019

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: 01/18/2020
• Device Model Number: TV-AB2980-J
• Device Catalogue Number: TV-AB2980-J
• Device Lot Number: FS120916-30
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/25/2019
• Supplement Date Received by Manufacturer: 11/25/2019
• Initial Report FDA Received Date: 12/23/2019
• Supplement Report FDA Received Date: 07/29/2020
• 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: FILL POLYMER, LOT # FF041817-01.; ILIAC LIMB, LOT # FS011317-05.; ILIAC LIMB, LOT # FS120616-47.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 86 YR