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

Model Number TV-AB3480-J

Device Problems Leak/Splash (1354); No Apparent Adverse Event (3189)

Patient Problem Failure of Implant (1924)

Event Date 11/30/2018

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 previously implanted with the ovation abdominal stent graft system to treat an abdominal aortic aneurysm (aaa).Approximately nine (9) months post initial procedure, a type ia and/or ii endoleak were discovered on a ct with no evidence of sac growth.As of the date of this report, there have been no additional patient sequelae reported and the patient will continue to be monitored.

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 denied response were 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.

Event Description

Subsequent to the initial report, additional information was received reporting that a review of the films was completed with the implanting physician who believes the aaa is getting smaller and feels the endoleak is a type ii endoleak form the lumbar artery and the patient is not symptomatic.The physician is electing to bring the patient back in -3 months for an additional cat scan.If the aaa shows growth re-intervention will be performed.Based on the above information a complaint is not warranted since there is no alleged deficiency related to identity, quality, durability, reliability, safety, effectiveness, or performance of the device.

• 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: 8201514
• MDR Text Key: 131582326
• Report Number: 3008011247-2018-00265
• Device Sequence Number: 1
• Product Code: MIH
• 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: 11/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/16/2021
• Device Model Number: TV-AB3480-J
• Device Catalogue Number: TV-AB3480-J
• Device Lot Number: FS010218-57
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/03/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 86 YR