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

Model Number TV-AB3480-J

Device Problems Malposition of Device (2616); Unintended Movement (3026)

Patient Problem Failure of Implant (1924)

Event Date 02/22/2019

Event Type  Injury  

Manufacturer Narrative

Endologix will continue to investigate the reported event.The patient medical records and imaging studies have been requested for further evaluation by a clinical specialist.A final report will be submitted once the investigation of the reported event has concluded.

Event Description

An ovation ix abdominal stent graft system was implanted to treat an abdominal aortic aneurysm.Reportedly, during the index procedure, the graft was placed slightly low with a 1-2 mm distal movement at post dilatation with coda balloon.Approximately one (1) month post op, during a follow-up ct scan, a type ia endoleak was identified.Reportedly, the patient was doing well.It was stated that the aaa was unchanged in size.Successful re-intervention was completed with implant of a non-endologix (palmaz) stent, coiling of proximal leak and post dilatation with a coda balloon and a atlas balloon.The patient tolerated procedure well.

Manufacturer Narrative

A clinical 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 no response was received.As such, event determination, off-label conditions, related patient harms, and patient disposition could not be independently assessed.The manufacturing lot review confirmed all devices met specifications prior to release.These types of events will be monitored and trended as part of the quality system.

• 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: 8493942
• MDR Text Key: 141307117
• Report Number: 3008011247-2019-00057
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: M701TVAB3480J1
• UDI-Public: +M701TVAB3480J1/$$3210910FS090618539
• 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
• Type of Report: Initial,Followup
• Report Date: 03/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/10/2021
• Device Model Number: TV-AB3480-J
• Device Catalogue Number: TV-AB3480-J
• Device Lot Number: FS090618-53
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: OVATION IX ILIAC LIMB (LN FS092118-24).; OVATION IX ILIAC LIMB (LN FS092218-18).
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR