MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number BEA28-90/I20-30

Device Problem Separation Problem (4043)

Patient Problem Aneurysm (1708)

Event Date 01/29/2024

Event Type  Injury  

Event Description

The patient was being treated for an endovascular aneurysm repair (evar) (b)(6) 2023 with the implant of an afx2 bifurcated stent graft (bsg) and an afx vela suprarenal.A routine follow up in 2022 identified implant separation with possible type iiia endoleak.Treatment was not performed.Patient status at the time was not provided.(reported under mfr# 3011063223-2024-00026).The distributor was notified in late january 2024, the physician noticed complete separation of afx2 bsg and afx vela suprarenal.Additionally, rapid aneurysm enlargement was observed.Reintervention was completed on (b)(6) 2024.Left access was obtained and an afx vela infrarenal and an afx vela suprarenal were implanted.Balloon touch-up was performed and no endoleaks were observed.The reintervention was completed.

Manufacturer Narrative

The reported incident was investigated in alignment with endologix operating procedures and work instructions.Where possible, it is endologix practice to make at least three good faith efforts to retrieve a reported adverse event/incident related device as well as medical records and medical imaging.An evaluation of the manufacturing record was completed.A review of the part number/lot number combination needed for device identification shows the device to have been properly manufactured and released in accordance with the device master record.Endologix was unable to perform an evaluation of the device as it remains implanted in the patient.A clinical evaluation of the adverse event/incident could not be completed.No medical records nor medical imaging relevant to the reported adverse event/incident was received by endologix.The user facility was unable to provide this information.Due to the absence of medical records and medical imaging device, use, procedure, and/or anatomy relatedness to this incident could not be evaluated.The final patient status remains unknown.The final patient status was not made available to endologix.No additional investigation of this reported adverse event/incident is planned.However, should additional information relevant to the investigation outcome become available, a follow-up report will be submitted.Endologix will continue to monitor this and similar incidents.Device iteration is afx2.

• Brand Name: AFX2
• 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: 18793381
• MDR Text Key: 336394842
• Report Number: 3011063223-2024-00027
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P040002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 02/06/2024

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 Expiration Date: 07/31/2022
• Device Model Number: BEA28-90/I20-30
• Device Lot Number: 1932746-004
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/06/2024
• Initial Date FDA Received: 02/27/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/20/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-0007-2019
• Patient Sequence Number: 1
• Treatment: AFX VELA SUPRARENAL (LN 2277444-007)
• Patient Outcome(s): Required Intervention
• Patient Sex: Male