MAUDE Adverse Event Report: ENDOLOGIX, INC. AFX; BIFURCATED STENT GRAFT

Model Number BA28-90/I20-30

Device Problems Deformation Due to Compressive Stress (2889); Insufficient Information (3190)

Patient Problem Failure of Implant (1924)

Event Date 11/06/2019

Event Type  Injury  

Manufacturer Narrative

The devices involved in this event will not be returned for evaluation and remain implanted in the patient.If additional information is obtained at a later time that is pertinent to this event, a follow-up report will then be submitted.Insufficient device information received to determine device iteration.Device iteration will be provided when further information.

Event Description

The patient was initially treated for an abdominal aortic aneurysm (aaa) with the afx abdominal aortic aneurysm stent.Approximately three and a half (3.5) years post initial procedure, the patient presented with an unknown device failure.The physician plans to re-intervene and will continue to monitor the patient.As of date, there have been no additional patient sequelae reported.There is limited information available regarding the initial reported event.

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.At the completion of the clinical assessment, the reported unknown device failure was identified as a type 3a endoleak with buckling of the bifurcated stent graft.Procedure related harms, device, user, procedure or anatomy relatedness of this event could not be determined with the medical records / images available for review.The following contributing factors were identified; the proximal extension was not in optimal position.It is not possible to determine migration vs suboptimal implant placement without comparative imaging.The extreme 82° aortic angulation likely contributed to the type 3a endoleak.It is not possible to identify whether this was an off-label condition or was due to aortic remodeling without comparative imaging.The buckling of the main body was most likely due to the extreme angulation of the aorta.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.Device iteration is afx with duraply.Corrections: h6: device code: remove code 3190 h6: result code: remove code 3233 h6: conclusion code: remove code 11.

Event Description

The patient was initially treated for an abdominal aortic aneurysm (aaa) with the afx abdominal aortic aneurysm stent.Approximately three and a half (3.5) years post initial procedure, the patient presented with an unknown device failure.The physician plans to re-intervene and will continue to monitor the patient.As of date, there have been no additional patient sequelae reported.There is limited information available regarding the initial reported event.Additional information received: the patient was initially implanted with a bifurcated stent graft and a suprarenal stent graft extension to treat an abdominal aortic aneurysm (aaa).The reported unknown device failure was identified to be a type 3a endoleak and buckling of the bifurcated stent graft.No further information was provided regarding the re- intervention.

• Brand Name: AFX
• Type of Device: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX, INC.; 2 musick; irvine CA 92618
• MDR Report Key: 9527733
• MDR Text Key: 175056208
• Report Number: 2031527-2019-00628
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• PMA/PMN Number: P040002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 11/27/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 01/07/2019
• Device Model Number: BA28-90/I20-30
• Device Lot Number: 1434493-019
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/27/2019
• Initial Date FDA Received: 12/27/2019
• Supplement Dates Manufacturer Received: 11/27/2019
• Supplement Dates FDA Received: 05/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-0006-2019
• Patient Sequence Number: 1
• Treatment: VELA SUPRARENAL, LOT 1346818008
• Patient Outcome(s): Other
• Patient Age: 75 YR