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

Model Number TV-AB2380-J

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

Patient Problems Failure of Implant (1924); No Consequences Or Impact To Patient (2199)

Event Date 08/27/2018

Event Type  Injury  

Manufacturer Narrative

The device remains implanted in the patient and will not be returned for evaluation.If additional information pertinent to the incident is obtained, a follow-up report will be submitted.

Event Description

An ovation ix abdominal stent graft system was implanted to treat an abdominal aortic aneurysm.There was a type 1a intraoperative endoleak.A non-endologix stent was placed; however, it did not completely resolve endoleak.The patient was reported to be stable.There is not a secondary procedure planned.The patient will be rescanned in approximately 30 days.No additional event or patient information is available.

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.B1: adverse event and product problem unchecked - correction.H6: patient codes - 1924 removed, correction.H6: device codes - 1354 removed, correction.H6: results codes - 3233 removed, correction.H6: conclusion codes - 11 removed, correction.

Event Description

Subsequent to the submitted initial report, additional information was provided reporting that the type ia endoleak resolved on its own and re-intervention was not required.

• 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: 7910458
• MDR Text Key: 121754059
• Report Number: 3008011247-2018-00206
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Public: +M701TVAB2380J1/$$3210504FS04301853+
• 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: 08/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/04/2021
• Device Model Number: TV-AB2380-J
• Device Catalogue Number: TV-AB2380-J
• Device Lot Number: FS043018-53
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: OVATION IX ILIAC LIMB (LN FS071917-31); OVATION IX ILIAC LIMB (LN FS111116-44); OVATION IX ILIAC LIMB (LN FS071917-31); OVATION IX ILIAC LIMB (LN FS111116-44)
• Patient Outcome(s): Other
• Patient Age: 84 YR