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 Codes	Aneurysm (1708); Failure of Implant (1924)
Date of Event	07/31/2019
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
The patient was initially treated with the ovation ix abdominal stent graft system.The aortic main body landed and deployed as expected.Polymer mix and fill completed as expected.The final run revealed a type ia endoleak present.The physician elected to balloon at the level of the sealing rings however, the endoleak remained.A decision was made to conclude the case and monitor the patient.
Additional Manufacturer Narrative
Clinical assessment was completed based on the received medical records.The reported event of the final run at the initial implant revealing a type 1a endoleak and the persistent endoleak that was left untreated was confirmed.The type 1a endoleak is most likely anatomy related as there was calcium (cautionary product use) observed in the aortic neck in the procedure planning report and no availability of bare metal stent during the initial implant procedure.The procedure related harms for this complaint could not be determined.The final patient status reported under surveillance.The device remains implanted; therefore, no device evaluation was completed.The manufacturing lot evaluation confirmed all devices met specifications prior to release.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 - updated h6: patient code - remove 1708 h6: device code - remove 3190 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: 8938194
• Report Number: 3008011247-2019-00133
• Device Sequence Number: 2000732
• Product Code: MIH
• UDI-Device Identifier: M701TVAB2680J1
• UDI-Public: +M701TVAB2680J1/$$3220110FS12051835$
• 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): 07/31/2019

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: 01/10/2022
• Device Model Number: TV-AB2680-J
• Device Catalogue Number: TV-AB2680-J
• Device Lot Number: FS120518-35
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/31/2019
• Supplement Date Received by Manufacturer: 07/31/2019
• Initial Report FDA Received Date: 08/27/2019
• Supplement Report FDA Received Date: 08/12/2020
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 75 YR