BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AGILE ESOPHAGEAL

    MDR report key: 21021151 · Received December 26, 2024

    Report

    Report Number
    3005099803-2024-06620
    Event Type
    Malfunction
    Date Received
    December 26, 2024
    Date of Event
    August 29, 2024
    Report Date
    December 26, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    ESW
    UDI-DI
    00191506006631
    PMA / PMN Number
    K211960
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK D4, H4: THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER. THEREFORE, THE MANUFACTURE AND EXPIRATION DATES ARE UNKNOWN. BLOCK G4: PREMARKET/510(K): K211960, K233837; REPORTED HERE AS IT EXCEEDED THE MAXIMUM CHARACTER LIMIT FOR THE DESIGNATED FIELD. BLOCK H6: IMDRF DEVICE CODE A010402 CAPTURES THE REPORTABLE EVENT OF STENT MIGRATION.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AGILE ESOPHAGEAL FULLY COVERED OVER-THE-WIRE STENT WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2024. THE STENT WAS ABLE TO BE DEPLOYED SATISFACTORILY. ON (B)(6) 2024, COMPLETE DISTAL STENT MIGRATION WAS NOTED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. NOTE: NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2428806 AGILE ESOPHAGEAL PROSTHESIS, ESOPHAGEAL ESW BOSTON SCIENTIFIC CORPORATION M00517760 00191506006631

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown