MAUDE Adverse Event Report: ENDOLOGIX AFX; BIFURCATED STENT GRAFT

Model Number BEA25-110/I16-30

Device Problem Deformation Due to Compressive Stress (2889)

Patient Problems Abdominal Pain (1685); Vascular Dissection (3160)

Event Date 04/11/2024

Event Type  Injury  

Event Description

The patient was emergently treated for abdominal pain with implant of an afx2 bifurcated stent graft on (b)(6) 2024.Approximately one week post initial procedure during follow up, an abdominal aneurysm was ruled out and the patient was still complaining of abdominal pain.Upon further follow up a thoracoabdominal dissection was found that compressed the afx2 stent graft.The physician elected to implant an afx vela infrarenal aortic extension to restore flow to the lumen of the bifurcated stent graft.The result of the procedure was good.The patient will have to complete the procedure with a fenestrated cuff to exclude the proximal dissection at a later date.

Manufacturer Narrative

The device involved in this event will not be returned for evaluation as it remains implanted in the patient.Patient medical records and imaging studies will be requested for further evaluation by the clinical specialist.If additional information pertinent to the incident is obtained, a follow-up report will be submitted.Device iteration is afx2 h3 other text : device remains implanted.

• Brand Name: AFX
• Type of Device: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• Manufacturer (Section G): ENDOLOGIX; 2 musick; ,; irvine CA 92618
• Manufacturer Contact: gary kirchgater ; 2 musick; ,; irvine, CA 92618 ; 8009832284
• MDR Report Key: 19188384
• MDR Text Key: 341115894
• Report Number: 3011063223-2024-00062
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00818009012098
• UDI-Public: (01)00818009012098(17)261109
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P040002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 04/11/2024

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 Model Number: BEA25-110/I16-30
• Device Lot Number: 2734159002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/11/2024
• Initial Date FDA Received: 04/25/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male