MAUDE Adverse Event Report: ENDOLOGIX AFX

Model Number BA25-110/I16-30

Device Problem Leak/Splash (1354)

Patient Problems Aneurysm (1708); Failure of Implant (1924)

Event Date 11/29/2018

Event Type  Injury  

Manufacturer Narrative

The device involved in the event will not be returned for evaluation as it remains implanted in the patient.If additional information pertinent to the incident is obtained, a follow-up report will be submitted.

Event Description

The patient was initially implanted with a bifurcated stent graft to treat an abdominal aortic aneurysm (aaa).Approximately 4.5 years post initial procedure during a routine follow up, an indeterminate endoleak with sac growth was discovered.A secondary procedure was completed.The physician elected to implant another bifurcated stent graft and an suprarenal stent extension to treat the reported the event.The patient was reported as doing fine post secondary procedure.As of the date of this report, there have been no additional patient sequelae reported.

Manufacturer Narrative

During the investigation of this case, it was discovered that this was a duplicate report.This event was previously reported under 2031527-2017-00674.A follow up was submitted under this reporting #.This event has been cancelled.

• Brand Name: AFX
• Type of Device: AFX
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 8205102
• MDR Text Key: 131695913
• Report Number: 2031527-2018-00972
• 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
• Type of Report: Initial,Followup
• Report Date: 11/29/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2014
• Device Model Number: BA25-110/I16-30
• Device Lot Number: 1200663-009
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/29/2018
• Initial Date FDA Received: 12/28/2018
• Supplement Dates Manufacturer Received: 11/29/2018
• Supplement Dates FDA Received: 02/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR