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

Model Number	TV-AB2680-J
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	06/13/2019
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
An ovation ix abdominal stent graft system was implanted to treat an abdominal aortic aneurysm.During the procedure a possible type ia endoleak was observed however, there were visualization difficulties.The physician elected to implant a palmaz stent graft proactively.The post angiogram appeared similar with continued visualization issues.The physician concluded the case and plans to follow-up during routine surveillance.The patient will continue to be monitored.
Additional Manufacturer Narrative
Clinical assessment was completed based on the received medical records.The reported intraoperative type 1a endoleak treated with a non-endologix bare metal stent was confirmed.The contributing factors for the intraoperative proximal loss of seal could not be identified due to the lack of the pre implant medical images and intraoperative angiogram.The final patient status was reported being stable and under surveillance.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.Corrections: g1,2: contact office- name has been updated.H6: result code ¿ remove 3233.H6: conclusion code ¿ remove 11.

• Brand Name: OVATION IX
• Common Device Name: AORTIC MAIN BODY
• Manufacturer (Section D): ENDOLOGIX (TRIVASCULAR); 3910 brickway blvd; santa rosa CA 95403
• MDR Report Key: 8784902
• Report Number: 3008011247-2019-00110
• Device Sequence Number: 2398000
• Product Code: MIH
• UDI-Device Identifier: M701TVAB2680J1
• UDI-Public: +M701TVAB2680J1/$$3220419FS041219066
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2019

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: 04/19/2022
• Device Model Number: TV-AB2680-J
• Device Catalogue Number: TV-AB2680-J
• Device Lot Number: FS041219-06
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/13/2019
• Supplement Date Received by Manufacturer: 06/13/2019
• Initial Report FDA Received Date: 07/12/2019
• Supplement Report FDA Received Date: 07/13/2020
• 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 CUSTOM SEAL FILL POLYMER.; OVATION IX ILIAC LIMB.; OVATION IX ILIAC LIMB.; PALMAZ STENT.; OVATION CUSTOM SEAL FILL POLYMER; OVATION IX ILIAC LIMB; OVATION IX ILIAC LIMB; PALMAZ STENT
• Outcome Attributed to Adverse Event: Other
• Patient Age: 88 YR