MAUDE Adverse Event Report: ENDOLOGIX (TRIVASCULAR, INC) OVATION IX; MAIN BODY

Model Number TV-AB3480-J

Device Problems Material Invagination (1336); Leak/Splash (1354)

Patient Problem Failure of Implant (1924)

Event Date 11/21/2018

Event Type  Injury  

Manufacturer Narrative

The lot history records related to the subject device referenced in this complaint record were reviewed for potential contributing factors for the failure mode(s) described in this event.A review of the device quality records showed that the device(s) demonstrated compliance to established procedures and specifications at the time of manufacture.

Event Description

The patient was initially treated with the ovation ix abdominal stent graft system.Approximately two (2) years post- op, a type ia endoleak and infolding at the level of the sealing rings were detected.No additional information was provided and there have been no patient sequelae reported.

Manufacturer Narrative

Clinical assessment was performed based off the provided medical records.The reported type ia endoleak and the seal ring infolding was confirmed.These events are most likely user-related as there was no contrast used for the sizing ct as well as a thick slice.Procedure related harms could not be determined; the final patient disposition was not reported and could not be determined.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.

Event Description

Subsequent to the initial report, additional information was provided reporting that successful re-intervention was completed with implant of an ovation ix extender, a non-endologix (palmaz) stent and ballooning at the level of the sealing rings.

• Brand Name: OVATION IX
• Type of Device: MAIN BODY
• Manufacturer (Section D): ENDOLOGIX (TRIVASCULAR, INC); 3910 brickway blvd.; santa rosa CA 95403
• MDR Report Key: 8192172
• MDR Text Key: 131300863
• Report Number: 3008011247-2018-00263
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: M701TVAB2680J1
• UDI-Public: +M701TVAB2680J1/$$3210622FS06151839B
• Combination Product (y/n): N
• PMA/PMN Number: P120006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 11/21/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2019
• Device Model Number: TV-AB3480-J
• Device Catalogue Number: TV-AB3480-J
• Device Lot Number: FS011616-54
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/21/2018
• Initial Date FDA Received: 12/21/2018
• Supplement Dates Manufacturer Received: 01/04/2019
• Supplement Dates FDA Received: 03/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 87 YR