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

Model Number	TV-AB2080-J
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/24/2019
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
An ovation ix abdominal stent graft system and an additional ovation ix iliac limb were implanted to treat an abdominal aortic aneurysm (aaa).Reportedly, the system deployed as expected.The final angio identified a possible type ia endoleak.The patient will be monitored and re-scanned in 30 days to determine if the type ia endoleak resolves on its own.
Additional Manufacturer Narrative
Clinical assessment was completed based on the received medical records.The reported the type ia endoleak (intraoperative) was unconfirmed due to a lack of medical imaging, several attempts were made for medical images but were denied as patient authorization is needed.Device, user, procedure or anatomy relatedness of this event could not be determined.The final patient status was discharge on the first post-operative day stable home.The manufacturing lot evaluation confirmed all devices met specifications prior to release.The device remains implanted; therefore, no device evaluation was completed.No additional investigation of this reported event is planned; however, if additional information pertinent to the incident is obtained, a follow-up report will be submitted.Endologix will continue to monitor this complaint and similar complaints in the event further investigation is needed.

• Brand Name: OVATION IX
• Common Device Name: MAIN BODY
• Manufacturer (Section D): ENDOLOGIX (TRIVASCULAR INC.); 3910 brickway blvd.; santa rosa CA 95403
• MDR Report Key: 8628842
• Report Number: 3008011247-2019-00083
• Device Sequence Number: 1968618
• Product Code: MIH
• UDI-Device Identifier: M701TVAB2080J1
• UDI-Public: +M701TVAB2080J1/$$3220206FS012519290
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P120006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,literatur
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/06/2022
• Device Model Number: TV-AB2080-J
• Device Catalogue Number: TV-AB2080-J
• Device Lot Number: FS012519-29
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/24/2019
• Supplement Date Received by Manufacturer: 04/24/2019
• Initial Report FDA Received Date: 05/21/2019
• Supplement Report FDA Received Date: 07/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: OVATION IX ILIAC LIMB (LN FS081718-38).; OVATION IX ILIAC LIMB (LN FS092017-44).; OVATION IX ILIAC LIMB (LN FS103118-24).; OVATION IX ILIAC LIMB (LN FS081718-38); OVATION IX ILIAC LIMB (LN FS092017-44); OVATION IX ILIAC LIMB (LN FS103118-24)
• Outcome Attributed to Adverse Event: Other
• Patient Age: 75 YR