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

Model Number	TV-AB2380-J
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	08/21/2019
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.Approximately two (2) years post-op a type ia endoleak was detected during follow-up.The patient is reported in stable condition.The physician plans to treat the patient at a later date.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 by video only.Additionally, it was determined that there was evidence to reasonably suggest a secondary endovascular procedure for left iliac non endologix stent placement and coiling of a lumbar artery (type ii endoleak (non-device related) occurred on (b)(6) 2017, that was not included in the event as reported.Device, user, procedure or anatomy relatedness of the type ia endoleak could not be determined.The final patient status was reported to be under surveillance pending a secondary endovascular procedure.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: b5: describe event or problem: updated.G1,2: contact office: name has been updated.H6: result code ¿ remove 3233.H6: conclusion code ¿ remove 11.
Event or Problem Description
An ovation ix abdominal stent graft system was implanted to treat an abdominal aortic aneurysm.Approximately two (2) years post-op a type ia endoleak was detected during follow-up.The patient is reported in stable condition.The physician plans to treat the patient at a later date.The patient will continue to be monitored.Subsequent to the initial report, clinical assessment determined that there was evidence to reasonably suggest a secondary endovascular procedure for left iliac with non endologix stent placement and coiling of a lumbar artery (type ii endoleak (non-device related) occurred on (b)(6) 2017 that was not included in the event as reported.

• 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: 9091611
• Report Number: 3008011247-2019-00141
• Device Sequence Number: 2425141
• Product Code: MIH
• UDI-Device Identifier: M701TVAB2380J1
• UDI-Public: +M701TVAB2380J1/$$3200828FS080517339
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P120006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2019

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: 08/28/2020
• Device Model Number: TV-AB2380-J
• Device Catalogue Number: TV-AB2380-J
• Device Lot Number: FS080517-33
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/21/2019
• Supplement Date Received by Manufacturer: 08/21/2019
• Initial Report FDA Received Date: 09/19/2019
• 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: OVATION CUSTOM SEAL FILL POLYMER; OVATION IX ILIAC LIMB (3)
• Outcome Attributed to Adverse Event: Other
• Patient Age: 82 YR