MAUDE Adverse Event Report: ENDOLOGIX (TRIVASCULAR INC.) OVATON IX; MAIN BODY

Model Number	TV-AB3480-E
Medical Device Problem Codes	Occlusion Within Device (1423); Improper or Incorrect Procedure or Method (2017); Malposition of Device (2616); Material Deformation (2976)
Health Effect - Clinical Codes	Failure of Implant (1924); Ischemia (1942); Stenosis (2263)
Date of Event	05/20/2018
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
Ovation devices were implanted to treat an abdominal aortic aneurysm on (b)(6) 2018.On (b)(6) 2018 the patient was re-admitted for lower limb claudication.The device was noted to have been implanted about 5 mm too low, as a result in-folding of the second sealing ring.A secondary procedure is being planned.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.
Event or Problem Description
A secondary procedure was performed and a non- endologix (palmaz) stent was implanted to resolved this leak.Patient did well post re-intervention there have been no additional patient sequelae reported.

• Brand Name: OVATON IX
• Common Device Name: MAIN BODY
• Manufacturer (Section D): ENDOLOGIX (TRIVASCULAR INC.); 3910 brickway blvd.; santa rosa CA 95403
• MDR Report Key: 7623479
• Report Number: 3008011247-2018-00144
• Device Sequence Number: 1623790
• Product Code: MIH
• UDI-Device Identifier: M701TVAB3480E1
• UDI-Public: +M701TVAB3480E1/$$3180814FS050415365
• Combination Product (Y/N): N
• Initial Reporter Country: RP
• 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): 05/23/2018

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: 08/14/2018
• Device Model Number: TV-AB3480-E
• Device Catalogue Number: TV-AB3480-E
• Device Lot Number: FS050415-36
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/23/2018
• Supplement Date Received by Manufacturer: 05/23/2018
• Initial Report FDA Received Date: 06/20/2018
• Supplement Report FDA Received Date: 09/19/2018
• 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 # FS031018-09; ILIAC LIMB, LOT # FS120617-69
• Outcome Attributed to Adverse Event: Other; Required Intervention