BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AGILE ESOPHAGEAL

    MDR report key: 21280068 · Received January 30, 2025

    Report

    Report Number
    3005099803-2025-00240
    Event Type
    Injury
    Date Received
    January 30, 2025
    Date of Event
    January 8, 2025
    Report Date
    January 30, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    ESW
    UDI-DI
    08714729973089
    PMA / PMN Number
    K180144
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    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)#: K233837: REPORTED HERE AS THE PREMARKET/510(K)# EXCEEDED CHARACTER LIMIT FOR THE DESIGNATED FIELD. BLOCK H6: IMDRF DEVICE CODE A010402 CAPTURES THE REPORTABLE EVENT OF STENT MIGRATION. IMDRF IMPACT CODE F2301 CAPTURES THE REPORTABLE EVENT OF NEW STENT WAS PLACED.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AGILE ESOPHAGEAL FULLY COVERED STENT TTS WAS IMPLANTED IN THE ESOPHAGUS TO TREAT AN ESOPHAGEAL STRICTURE DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE STENT WAS SUCCESSFULLY DEPLOYED. THE PATIENT UNDERWENT THERAPY, AND IT WAS NOTED THAT THE STENT HAD MIGRATED. ANOTHER WALLFLEX STENT WAS PLACED, AND THE PHYSICIAN PLANS TO REMOVE THE MIGRATED STENT IN APPROXIMATELY 3 WEEKS. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2230633 AGILE ESOPHAGEAL PROSTHESIS, ESOPHAGEAL ESW BOSTON SCIENTIFIC CORPORATION M00517460 08714729973089

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Male Required Intervention