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

Model Number	TV-AB2680-E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	09/13/2018
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 prime endovascular sealing system was implanted to treat an abdominal aortic aneurysm.During a routine follow up, sac growth was discovered with no endoleak present.Sac growth was approximately 51mm to 65mm equaling 14mm growth.A ct was preformed and there was still no endoleak present.On (b)(6) 2018, a non-endologix stent was implanted to resolve the sac growth.The patient was reported as doing fine post-secondary procedure.No additional event or patient information was provided.
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 inadequate response was 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 PRIME
• Common Device Name: MAIN BODY
• Manufacturer (Section D): ENDOLOGIX (TRIVASCULAR INC.); 3910 brickway blvd.; santa rosa CA 95403
• MDR Report Key: 7964031
• Report Number: 3008011247-2018-00222
• Device Sequence Number: 1434085
• Product Code: MIH
• UDI-Device Identifier: M701TVAB2680E1
• UDI-Public: +M701TVAB2680E1/$$3170924FS070214243
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P120006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/14/2018

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: 09/24/2017
• Device Model Number: TV-AB2680-E
• Device Catalogue Number: TV-AB2680-E
• Device Lot Number: FS070214-24
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/14/2018
• Supplement Date Received by Manufacturer: 10/19/2018
• Initial Report FDA Received Date: 10/15/2018
• Supplement Report FDA Received Date: 01/31/2019
• 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: OVATION PRIME ILIAC LIMB (LN FS040114-27); OVATION PRIME ILIAC LIMB (LN FS070914-76); OVATION PRIME ILIAC LIMB (LN FS040114-27); OVATION PRIME ILIAC LIMB (LN FS070914-76)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 86 YR