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

Model Number	TV-AB2980-E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/18/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device remains implanted in the patient and will not be returned for evaluation.If additional information pertinent to the incident is obtained, a follow-up report will be submitted.
Event or Problem Description
An ovation ix abdominal stent graft system was implanted to treat an abdominal aortic aneurysm.A type 1a endoleak was identified at a routine follow-up visit.Patient is reported to be stable.The treatment plan is to balloon with non-compliant balloon to try to gain a few mm's of diameter to oppose wall.Secondary treatment has not yet been scheduled.No additional event or patient information is available.
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.This complaint is not capa eligible at this time.These types of events will be monitored and trended as part of the quality system.
Event or Problem Description
Subsequent to the initial report, additional information was received reporting that the patient was treated with a noncompliant balloon to expand non-endologix stent slightly, leaving a very faint leak.No additional event or patient information is available.

• Brand Name: OVATION PRIME
• Common Device Name: MAIN BODY
• Manufacturer (Section D): ENDOLOGIX (TRIVASCULAR INC.); 3910 brickway blvd.; santa rosa CA 95403
• MDR Report Key: 8025038
• Report Number: 3008011247-2018-00237
• Device Sequence Number: 1368640
• Product Code: MIH
• UDI-Device Identifier: M701TVAB2980E1
• UDI-Public: +M701TVAB2980E1/$$3180312FS020415493
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P120006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/03/2018

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: 03/12/2018
• Device Model Number: TV-AB2980-E
• Device Catalogue Number: TV-AB2980-E
• Device Lot Number: FS020415-49
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/03/2018
• Supplement Date Received by Manufacturer: 12/11/2018
• Initial Report FDA Received Date: 10/31/2018
• Supplement Report FDA Received Date: 12/17/2018
• 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: OVATION PRIME ILIAC LIMB (LN FS081814-29); OVATION PRIME ILIAC LIMB (LN FS100614-19); OVATION PRIME ILIAC LIMB (LN FS081814-29); OVATION PRIME ILIAC LIMB (LN FS100614-19)
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 74 YR