BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AGILE ESOPHAGEAL

    MDR report key: 21389578 · Received February 14, 2025

    Report

    Report Number
    3005099803-2025-00303
    Event Type
    Malfunction
    Date Received
    February 14, 2025
    Date of Event
    January 17, 2025
    Report Date
    February 14, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    ESW
    PMA / PMN Number
    K211960
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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)#: K211960, 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.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AGILE STENT WAS IMPLANTED DURING AN ESOPHAGEAL STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2025 TO TREAT AN ESOPHAGEAL COMPRESSION CAUSED BY ANAL CANCER THAT METASTASIZED ON THE MEDIASTINUM. REPORTEDLY, THE STENT STAYED IN PLACE AND WAS CHECKED DAILY WITH X-RAYS. HOWEVER, IT WAS NOTICED THAT IT MIGRATED TO THE STOMACH ON (B)(6) 2025 AFTER A CASE OF REPORTED NAUSEA STEMMING FROM CONTRAST INJECTION TO RESTAGE THE CANCER. THE PHYSICIAN DECIDED TO LEAVE THE MIGRATED STENT INSIDE THE STOMACH AND REMOVE IT DURING A G-TUBE PLACEMENT PROCEDURE AT A LATER DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1117687 AGILE ESOPHAGEAL PROSTHESIS, ESOPHAGEAL ESW BOSTON SCIENTIFIC CORPORATION M00517780

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown