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	07/23/2018
Type of Reportable Event	Serious Injury
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.A requests were made on (b)(6) 2018 for medical records / images and was denied.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.
Event or Problem Description
On (b)(6) 2018, the patient was implanted the ovation system to treat an abdominal aortic aneurysm.On (b)(4) 2018, endologix was made aware of a type 1b endoleak.On (b)(6) 2018, the physician elected to implant an additional lliac limb.The endoleak was resolved.As of the date of this report, there have been no additional patient sequelae reported.

• 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: 7806164
• Report Number: 3008011247-2018-00183
• Device Sequence Number: 13738802
• Product Code: MIH
• UDI-Device Identifier: M701TVIL1416120J1
• UDI-Public: +M701TVIL1416120J1/$$3210508FS04171840N
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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
• Report Date (Section B): 07/23/2018

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: 05/08/2021
• Device Model Number: TV-IL1416120-J
• Device Catalogue Number: TV-IL1416120-J
• Device Lot Number: FS041718-40
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/23/2018
• Initial Report FDA Received Date: 08/22/2018
• 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: ILIAC LIMB, LOT # FS030118-60; MAIN BODY, LOT # FS042118-08
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR