MAUDE Adverse Event Report: ENDOLOGIX, LLC AFX2 BIFURCATED ENDOGRAFT SYSTEM; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number BEA25-70/I20-30

Device Problem Material Frayed (1262)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/18/2023

Event Type  malfunction  

Event Description

During an abdominal aortic endograft placement, the flexible wire at the end of an introducer (ref: (b)(4), manf: endologix) frayed into multiple sections.The introducer was removed from the patient and the frayed wires with it, multiple x-rays were performed to ensure no pieces of wire remained in the patient.Another device was opened to complete the procedure without further incident.

• Brand Name: AFX2 BIFURCATED ENDOGRAFT SYSTEM
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): ENDOLOGIX, LLC; 2 musick; irvine CA 92618
• MDR Report Key: 16784472
• MDR Text Key: 313720094
• Report Number: 16784472
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BEA25-70/I20-30
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/19/2023
• Event Location: Hospital
• Date Report to Manufacturer: 04/21/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/21/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 27740 DA
• Patient Sex: Male
• Patient Weight: 111 KG