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

Model Number	TV-AB2980-J
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/07/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device involved in this event will not be returned for evaluation as it remains implanted in the patient.Patient medical records and imaging studies will be requested for further evaluation by the clinical specialist.If additional information pertinent to the incident is obtained, a follow-up report will be submitted.
Event or Problem Description
The patient was initially treated with the ovation ix abdominal stent graft system to treat an abdominal aortic aneurysm (aaa).Approximately one (1) month post-op, a computed tomography (ct) was completed revealing the presence of a type ia endoleak.The patient condition was reported as good and the patient will continue to be monitored.
Additional Manufacturer Narrative
Clinical assessment was completed based on the received medical records.The reported type ia endoleak was confirmed.The type ia was most likely anatomy related as the thrombus and calcifications in the aortic neck likely contributed to the seal ring invagination resulting in the type ia endoleak.Procedure related harms for this complaint could not be determined.Additionally, clinical assessment determined that there was evidence to reasonably suggest type ii endoleak of the lumbar arteries occurred that was not included in the event as reported.The final patient status was not reported.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.
Event or Problem Description
The patient was initially treated with the ovation ix abdominal stent graft system to treat an abdominal aortic aneurysm (aaa).Approximately one (1) month post-op, a computed tomography (ct) was completed revealing the presence of a type ia endoleak.The patient condition was reported as good and the patient will continue to be monitored.Subsequent to the initial report, additional information was provided reporting that re-intervention was performed with successful coiling of the type ia endoleak.No further information was provided.Additionally, clinical assessment determined that there was evidence to reasonably suggest type ii endoleak (non-device related) of the lumbar arteries occurred that was not included in the event as reported.

• Brand Name: OVATION IX
• Common Device Name: MAIN BODY
• Manufacturer (Section D): ENDOLOGIX (TRIVASCULAR); 3910 brickway blvd; santa rosa CA 95403
• MDR Report Key: 9452890
• Report Number: 3008011247-2019-00177
• Device Sequence Number: 3066763
• Product Code: MIH
• UDI-Device Identifier: M701TVAB2980J1
• UDI-Public: +M701TVAB2980J1/$$3220813FS08091936K
• Combination Product (Y/N): N
• Initial Reporter State: SD
• 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): 11/11/2019

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: 08/13/2022
• Device Model Number: TV-AB2980-J
• Device Catalogue Number: TV-AB2980-J
• Device Lot Number: FS080919-36
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/11/2019
• Supplement Date Received by Manufacturer: 11/11/2019
• Initial Report FDA Received Date: 12/11/2019
• Supplement Report FDA Received Date: 07/15/2020
• 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: ILIAC LIMB, LOT # FS021219-12.; ILIAC LIMB, LOT # FS100318-31.; POLYMER, LOT # FF072619-01.; ILIAC LIMB, LOT # FS021219-12; ILIAC LIMB, LOT # FS100318-31; POLYMER, LOT # FF072619-01
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 76 YR