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

Model Number TV-AB3480-J

Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)

Patient Problems Aneurysm (1708); No Consequences Or Impact To Patient (2199)

Event Date 01/21/2019

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.A possible type 1a endoloeak was identified at the end of the procedure.Physician decided to not treat it at the time.Patient will be monitored and a 30 day post op ct will be performed to determine if possible type 1a endoleak has resolved.

Event Description

Subsequent to the initial report, additional information was provided reporting that the 30 day post op ct was performed and the type ia endoleak had resolved.

Manufacturer Narrative

Based on the additional information provided, a complaint is not warranted since there is no alleged deficiency related to identity, quality, durability, reliability, safety, effectiveness, or performance of the device therefore a root cause will not be identified.

• 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: 8352347
• MDR Text Key: 136586157
• Report Number: 3008011247-2019-00021
• 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
• Type of Report: Initial,Followup
• Report Date: 01/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/10/2021
• Device Model Number: TV-AB3480-J
• Device Lot Number: FS090618-45
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: OVATION IX ILIAC LIMB (LN FS021618-33).; OVATION IX ILIAC LIMB (LN FS070318-62).
• Patient Outcome(s): Other
• Patient Age: 76 YR