BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALLSTENT ENTERAL ENDOPROSTHESIS

    MDR report key: 1063048 · Received June 19, 2008

    Report

    Report Number
    3005099803-2008-00800
    Event Type
    Malfunction
    Date Received
    June 19, 2008
    Report Date
    May 22, 2008
    Manufacturer
    BOSTON SCIENTIFIC IRELAND, LTD.
    Product Code
    MQR
    PMA / PMN Number
    K000281
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THERAPY UNSUCCESSFUL - THE DEVICE MFR DATE IS UNK SINCE THE UPN AND LOT NUMBER WERE NOT ASCERTAINABLE FROM THE COMPLAINANT. THE DEVICE HAS NOT BEEN RETURNED. A DEVICE ANALYSIS CANNOT BE PERFORMED; THEREFORE, THE CAUSE OF THE REPORTED EVENT IS UNDETERMINED.

    Description of Event or Problem · 1

    IN 2008, A BOSTON SCIENTIFIC EMPLOYEE BECAME AWARE OF A CLINICAL STUDY ARTICLE, "COMPARISON OF WALLSTENT AND ULTRAFLEX STENTS FOR PALLIATION OF MALIGNANT LEFT). THE STUDY WAS A RETROSPECTIVE ANALYSIS TO COMPARE WALLSTENT AND ULTRAFLEX STENTS. THE FOLLOWING INFO WAS DERIVED FROM THIS ARTICLE: ON THE DAY OF PROCEDURE (PATIENT AGE, GENDER AND WEIGHT), THERE WAS A FAILED ATTEMPT TO PLACE THE STENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WALLSTENT ENTERAL ENDOPROSTHESIS MQR BOSTON SCIENTIFIC IRELAND, LTD. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other