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

Model Number	TV-IL1416120-J
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/16/2018
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
On (b)(6) 2018, the ovation endovascular sealing system was implanted to treat an abdominal aortic aneurysm.On (b)(6) 2018, endologix was made aware a indeterminate endoleak (possible type 2 or 3a) with no sac growth.No further information is available at this time.There have been no additional patient sequelae reported.
Additional Manufacturer Narrative
The manufacturing lot evaluation confirmed all devices met specifications prior to release.The device was not returned as the device remains implanted therefore no evaluation was completed.A clinical assessment of the reported event could not be completed due to a lack of receipt of relevant medical records and/or imaging.As such, event determination, off label conditions, related patient harms and patient disposition could not be independently assessed.Endologix continues to investigate this event and similar events to ensure the highest quality and patient safety.

• Brand Name: OVATION IX
• Common Device Name: ILIAC LIMB
• Manufacturer (Section D): ENDOLOGIX (TRIVASCULAR INC.); 3910 brickway blvd.; santa rosa CA 95403
• MDR Report Key: 7603970
• Report Number: 3008011247-2018-00136
• Device Sequence Number: 13511221
• Product Code: MIH
• UDI-Device Identifier: M701TVIL1416120J1
• UDI-Public: +M701TVIL1416120J1/$$3201025FS10051745F
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 05/16/2018

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: 10/25/2020
• Device Model Number: TV-IL1416120-J
• Device Catalogue Number: TV-IL1416120-J
• Device Lot Number: FS100517-45
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/16/2018
• Supplement Date Received by Manufacturer: 05/16/2018
• Initial Report FDA Received Date: 06/14/2018
• Supplement Report FDA Received Date: 09/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 79 YR