BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALLFLEX? ESOPHAGEAL

    MDR report key: 3843441 · Received June 2, 2014

    Report

    Report Number
    3005099803-2014-02119
    Event Type
    Injury
    Date Received
    June 2, 2014
    Date of Event
    May 9, 2014
    Report Date
    May 9, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    ESW
    PMA / PMN Number
    K091510
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL DEVICE INFO: THE COMPLAINANT WAS UNABLE TO REPORT THE LOT NUMBER; THEREFORE THE MANUFACTURE DATE AND EXPIRATION DATE ARE UNKNOWN. HOWEVER, THE COMPLAINANT STATED THAT THE DEVICE WAS USED PRIOR TO THE EXPIRATION DATE. (B)(4). THE COMPLAINANT INDICATED THAT THE DEVICE WAS DISPOSED 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 A WALLFLEX ESOPHAGEAL STENT WAS IMPLANTED IN THE ESOPHAGUS DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON (B)(6), 2014. ACCORDING TO THE COMPLAINANT, THE STENT WAS BEING IMPLANTED TO TREAT A TRACHEOESOPHAGEAL FISTULA. NO ISSUES WERE NOTED DURING STENT IMPLANTATION. ON (B)(6), 2014, THE PHYSICIAN REMOVED THE STENT BECAUSE IT WAS CAUSING PRESSURE ON THE TRACHEA. IT WAS A REPORTED THAT THE PRESSURE WAS RELIEVED AFTER STENT REMOVAL. THE PATIENT WAS SENT TO ANOTHER HOSPITAL FOR AN ADDITIONAL STENT PLACEMENT PROCEDURE. IT WAS REPORTED THAT THE PATIENT DIED ON AN UNKNOWN DATE. IN THE PHYSICIAN¿S ASSESSMENT, THE PATIENT¿S DEATH WAS DUE TO HER CONDITION AND THERE WAS NO RELATIONSHIP BETWEEN THE PATIENT¿S DEATH AND THE WALLFLEX ESOPHAGEAL STENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322089 WALLFLEX? ESOPHAGEAL PROSTHESIS, ESOPHAGEAL ESW BOSTON SCIENTIFIC - GALWAY M00516700

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention