BEUDAMED
    FDA Adverse Event Death Summary report: N

    WALLFLEX ENTERAL DUODENAL STENT

    MDR report key: 1328138 · Received February 26, 2009

    Report

    Report Number
    3005099803-2009-00811
    Event Type
    Death
    Date Received
    February 26, 2009
    Report Date
    January 30, 2009
    Manufacturer
    BOSTON SCIENTIFIC IRELAND, LTD.
    Product Code
    MUM
    PMA / PMN Number
    K062750
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUSPECT DEVICE LOT NUMBER IS UNKNOWN; THEREFORE, THE DEVICE EXPIRATION AND MANUFACTURE DATES ARE UNKNOWN. THE DEVICE IS NOT AVAILABLE. A DEVICE ANALYSIS CANNOT BE PERFORMED; THEREFORE, THE CAUSE OF THE REPORTED EVENT IS UNDETERMINED.

    Description of Event or Problem · 1

    IN EARLY 2009, A BOSTON SCIENTIFIC CORPORATION EMPLOYEE BECAME AWARE OF A CLINICAL STUDY ARTICLE, "FIRST DATA ON THE PALLIATIVE TREATMENT OF PATIENTS WITH MALIGNANT GASTRIC OUTLET OBSTRUCTION USING THE WALLFLEX ENTERAL STENT: A RETROSPECTIVE MULTICENTER STUDY" PUBLISHED IN ENDOSCOPY 2007; 30: 434-439. THE FOLLOWING INFORMATION WAS DERIVED FROM THIS ARTICLE: A WALLFLEX ENTERAL DUODENAL STENT WAS USED FOR A STENTING PROCEDURE. ACCORDING TO THE ARTICLE, A PATIENT DEVELOPED SEPSIS OF UNKNOWN ORIGIN. SEPSIS WAS POSSIBLY PROCEDURE-RELATED. PATIENT EXPIRED WITHIN ONE WEEK OF INCLUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WALLFLEX ENTERAL DUODENAL STENT MUM BOSTON SCIENTIFIC IRELAND, LTD. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death| O