MAUDE Adverse Event Report: ENDOLOGIX AFX; BIFURCATED STENT GRAFT

Model Number	F00756-01
Medical Device Problem Codes	Failure To Adhere Or Bond (1031); Leak/Splash (1354); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	09/11/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The devices involved in the event will not be returned for evaluation, they remain implanted in the patient.If additional information pertinent to the incident is obtained, a follow-up report will be submitted.
Event or Problem Description
The patient underwent an evar procedure to treat an abdominal aortic aneurysm.A medtronic endurant aorta extension was implanted first, the afx main body was implanted after.It was reported the endurant may have moved down from the original implant position.The overlap was noted to be shorter than planned between the aortic extension and afx main body.The physician elected to balloon, however a type iiia endoleak was observed.An afx suprarenal cuff extension was then implanted at the overlap portion, however the type iiia endoleak was not resolved.As of this report, there has been no patient sequela reported.
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.A clinical assessment of the reported event could not be completed due to a lack of receipt of relevant medical records and/or imaging.However the most likely cause of this event is user related as it was reported that a non- endologix device was implanted first and that that the non- endologix device may have moved.This is an off - label procedure.Endologix continues to investigate this event and similar events to ensure the highest quality and patient safety.

• Brand Name: AFX
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 6938684
• Report Number: 2031527-2017-00520
• Device Sequence Number: 16366792
• Product Code: MIH
• UDI-Device Identifier: 00818009010216
• UDI-Public: (01)00818009010216(17)191005
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physicist
• Type of Report: Initial,Followup
• Report Date (Section B): 09/13/2017

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?: Yes
• Operator of Device: Physician
• Device Expiration Date: 10/05/2019
• Device Model Number: F00756-01
• Device Lot Number: 1596614-002
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/13/2017
• Supplement Date Received by Manufacturer: 09/13/2017
• Initial Report FDA Received Date: 10/10/2017
• Supplement Report FDA Received Date: 10/24/2018
• 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: MEDTRONIC ENDURANT AORTA EXTENSION - LOT: UNKNOWN
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 81 YR