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

Model Number	TV-AB2380-E
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Aneurysm (1708)
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
The patient was initially treated for an abdominal aortic aneurysm (aaa) with the ovation prime abdominal stent graft system.Approximately 5.5 years post-op, aneurysm sac growth of approximately 1.5 cm was observed without the presence of endoleak.The physician elected to reline implanting two (2) additional ovation ix iliac limbs.The patient tolerated the procedure and will continue to be monitored.
Additional Manufacturer Narrative
The manufacturing lot evaluation confirmed all devices met specifications prior to release.The device was not returned as the device remains implanted therefore no evaluation was completed.An evaluation of the reported event shows is it most likely type ii from lumbar artery.The sac growth and secondary endovascular procedure event is confirmed.There is no known device malfunction.The event is most likely anatomy related.The procedure related harms identified were type ii endoleak.The final patient status was reported being monitored.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 for an abdominal aortic aneurysm (aaa) with the ovation prime abdominal stent graft system.Approximately 5.5 years post-op, aneurysm sac growth of approximately 1.5cm was observed without the presence of endoleak.The physician elected to reline implanting two (2) additional ovation ix iliac limbs.The patient tolerated the procedure and will continue to be monitored.Additional information: the reported no presence of endoleak was refuted as there was a type 2 endoleak identified during clinical assessment.This is a non- device related failure.

• 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: 9120912
• Report Number: 3008011247-2019-00148
• Device Sequence Number: 19313833
• Product Code: MIH
• UDI-Device Identifier: M701TVAB2380E1
• UDI-Public: +M701TVAB2380E1/$$3170724FS061014695
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P120006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2019

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: 07/31/2017
• Device Model Number: TV-AB2380-E
• Device Catalogue Number: TV-AB2380-E
• Device Lot Number: FS061014-69
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/26/2019
• Supplement Date Received by Manufacturer: 08/26/2019
• Initial Report FDA Received Date: 09/25/2019
• Supplement Report FDA Received Date: 08/07/2020
• 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 CUSTOM SEAL FILL POLYMER.; OVATION PRIME ILIAC LIMB (2).
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 83 YR