BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALLFLEX ESOPHAGEAL

    MDR report key: 11426752 · Received March 7, 2021

    Report

    Report Number
    3005099803-2021-00942
    Event Type
    Injury
    Date Received
    March 7, 2021
    Date of Event
    January 20, 2021
    Report Date
    March 5, 2021
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    ESW
    UDI-DI
    08714729778035
    PMA / PMN Number
    K091510
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINANT INDICATED THAT THE DEVICE WAS CONTAMINATED AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT ON FEBRUARY 11, 2021 A WALLFLEX ESOPHAGEAL FULLY COVERED STENT WAS IMPLANTED TO TREAT A STENOSIS IN THE MIDDLE ESOPHAGUS DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2021. ON (B)(^) 2021, THE PATIENT PRESENTED WITH DYSPHAGIA AND EMERGENCY IMAGING WAS PERFORMED. IT WAS NOTED THAT THE STENT MIGRATED TO THE GASTRIC CHAMBER. THE PATIENT'S ANATOMY WAS DILATED TO 15CM AND THE STENT WAS REMOVED TOGETHER WITH THE THREE CLIPS WHICH THAT WERE INTENDED TO KEEP THE STENT IN PLACE. A NEW STENT WAS NOT PLACED DURING THE PROCEDURE DUE TO THE DILATION SIZE OF THE ANATOMY. RADIOTHERAPY AND QUANTITATIVE MAGNETIZATION (QMT) WERE STARTED TO TREAT THE PATIENT WITH SOME IMPROVEMENTS, AND ANOTHER STENT WILL BE PLACED. NOTE: BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE, DESPITE GOOD FAITH EFFORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    326418 WALLFLEX ESOPHAGEAL PROSTHESIS, ESOPHAGEAL ESW BOSTON SCIENTIFIC CORPORATION M00516700 0026221911 08714729778035

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention