BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALLFLEX ENTERAL DUODENAL STENT

    MDR report key: 1328262 · Received February 27, 2009

    Report

    Report Number
    3005099803-2009-00878
    Event Type
    Injury
    Date Received
    February 27, 2009
    Report Date
    January 30, 2009
    Manufacturer
    BOSTON SCIENTIFIC IRELAND, LTD.
    Product Code
    MUM
    PMA / PMN Number
    K062750
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE MANUFACTURE DATE AND EXPIRATION DATE ARE UNKNOWN SINCE THE LOT NUMBER IS 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

    NOTE: DATE OF EVENT IS UNKNOWN. ON JANUARY 30, 2009, A BOSTON SCIENTIFIC EMPLOYEE BECAME AWARE OF A CLINICAL STUDY ARTICLE, "COMBINED ENDOSCOPIC STENT INSERTION IN MALIGNANT BILIARY AND DUODENAL OBSTRUCTION", BY M. MUTIGNANI, ET AL. ACCORDING TO THE ARTICLE, THE WALLFLEX ENTERAL DUODENAL STENT WAS USED IN A COMBINED ENDOSCOPIC STENT INSERTION. THE PATIENT DEVELOPED RECURRENT VOMITING DUE TO TUMOR INGROWTH. THE PATIENT WAS TREATED ENDOSCOPICALLY BY RE-STENTING. THERE IS NO FURTHER INFORMATION FROM THE ARTICLE REGARDING THE STATUS OF THE PATIENT.

    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 Other