MAUDE Adverse Event Report: ENDOLOGIX (TRIVASCULAR INC.) OVATION IX; MAIN BODY

Model Number	TV-AB2380-J
Medical Device Problem Code	Partial Blockage (1065)
Health Effect - Clinical Codes	Failure of Implant (1924); Occlusion (1984)
Date of Event	11/18/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device involved in the event will not be returned for evaluation as it remains implanted in the patient.If additional information pertinent to the incident is obtained, a follow-up report will be submitted.
Event or Problem Description
The patient was initially treated with the ovation ix abdominal aortic aneurysm sealing system.Thirteen (13) days post initial procedure, the patient presented with numbness in the right leg (limb occlusion).The physician elected to treat the patient the following day by implanting two (2) stent balloon (non-endologix) devices.The patient was stable when leaving the operating room.As of the date of this report, there have been no additional patient sequelae reported.
Additional Manufacturer Narrative
An evaluation of the reported event could not be completed due to a lack of receipt of relevant medical records and/or imaging.Requests were made and denied response were received.As such, event determination, off label conditions, related patient harms and patient disposition could not be independently assessed.The review of manufacturing lot confirmed all devices met specifications prior to release.No additional investigations of this reported complaint are planned.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 (TRIVASCULAR INC.); 3910 brickway blvd.; santa rosa CA 95403
• MDR Report Key: 8182681
• Report Number: 3008011247-2018-00260
• Device Sequence Number: 16418594
• Product Code: MIH
• UDI-Device Identifier: M701TVAB2380J1
• UDI-Public: +M701TVAB2380J1/$$3210713FS070318353
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2018

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/13/2021
• Device Model Number: TV-AB2380-J
• Device Catalogue Number: TV-AB2380-J
• Device Lot Number: FS070318-35
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/19/2018
• Supplement Date Received by Manufacturer: 01/04/2019
• Initial Report FDA Received Date: 12/19/2018
• Supplement Report FDA Received Date: 03/27/2019
• 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: EXTENDER, LOT FS072418-05.; EXTENDER, LOT FS072618-44.; ILIAC LIMB, LOT FS071318-59.; ILIAC LIMB, LOT FS071318-66.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 55 YR