BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AGILE ESOPHAGEAL

    MDR report key: 21424952 · Received February 20, 2025

    Report

    Report Number
    3005099803-2025-00589
    Event Type
    Malfunction
    Date Received
    February 20, 2025
    Date of Event
    January 31, 2025
    Report Date
    February 20, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    ESW
    UDI-DI
    00191506006631
    PMA / PMN Number
    K211960
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK G4: PREMARKET / 510(K)#: K233837 WAS REPORTED HERE AS THE PREMARKET/510(K)# EXCEEDED CHARACTER LIMIT FOR THE DESIGNATED FIELD. BLOCK H6: IMDRF DEVICE CODE A150207 CAPTURES THE REPORTABLE EVENT OF DELIVERY SYSTEM DIFFICULT TO REMOVE.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AGILE ESOPHAGEAL FULLY COVERED STENT OTW WAS TO BE IMPLANTED IN THE ESOPHAGUS TO TREAT AN ESOPHAGEAL CANCER DURING AN ESOPHAGEAL STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2025. THE PATIENT'S ANATOMY WAS NORMAL AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE STENT WAS ABLE TO BE DEPLOYED. HOWEVER, WHEN THE CATHETER WAS REMOVED, IT WAS NOTED THAT THE PROXIMAL END OF THE STENT WAS STILL ATTACHED TO THE CATHETER. THE STENT WAS REMOVED TOGETHER WITH THE CATHETER, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER AGILE ESOPHAGEAL STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    410538 AGILE ESOPHAGEAL PROSTHESIS, ESOPHAGEAL ESW BOSTON SCIENTIFIC CORPORATION M00517760 0034488891 00191506006631

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown