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

Model Number	TV-AB2380-E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Codes	Failure of Implant (1924); Stenosis (2263)
Date of Event	02/15/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Endologix will continue to investigate the reported event.The patient medical records and imaging studies will be requested for further evaluation by a clinical specialist.A final report will be submitted once the investigation of the reported event has concluded.
Event or Problem Description
An ovation prime abdominal stent graft system was implanted to treat an abdominal aortic aneurysm.The patient returned approximately 4 years post index procedure with a type ia endoleak.The physician elected to re-intervene by placing a non-endologix cuff at the level of the sealing rings, successfully resolving the endoleak.It was also noted during the re-intervention that there was narrowing of the aortic neck at the level of the sealing rings.As of the date of this report, there have been no additional patient sequelae reported.
Additional Manufacturer Narrative
Based on the clinical assessment for this event, the most likely cause of the proximal loss of seal was found to be anatomy related due to the calcium observed in the neck during pre implant imaging.Procedure related harms and the final patient disposition could not be ascertained due to the lack of medical information surrounding the event, however, there have been no additional reports of patient sequelae.A review of the device quality records shows that the device demonstrated compliance to established procedures and specifications at the time of manufacture.(b)(4).

• 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: 7331142
• Report Number: 3008011247-2018-00032
• Device Sequence Number: 1476725
• Product Code: MIH
• UDI-Device Identifier: M701TVAB2380E1
• UDI-Public: +M701TVAB2380E1/$$3170822FS06201433$
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/15/2018

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/22/2017
• Device Model Number: TV-AB2380-E
• Device Catalogue Number: TV-AB2380-E
• Device Lot Number: FS062014-33
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/15/2018
• Supplement Date Received by Manufacturer: 02/15/2018
• Initial Report FDA Received Date: 03/12/2018
• Supplement Report FDA Received Date: 05/24/2018
• 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: TV-IL1412140-E; OVATION PRIME ILIAC LIMB: TV-IL1414140-E
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 86 YR