BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALLSTENT ENTERAL ENDOPROSTHESIS

    MDR report key: 1327308 · Received February 25, 2009

    Report

    Report Number
    3005099803-2009-00741
    Event Type
    Injury
    Date Received
    February 25, 2009
    Report Date
    January 30, 2009
    Manufacturer
    BOSTON SCIENTIFIC IRELAND, LTD.
    Product Code
    MQR
    PMA / PMN Number
    K000281
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 UNK. IN EARLY 2009, A BOSTON SCIENTIFIC CORP EMPLOYEE BECAME AWARE OF A CLINICAL STUDY ARTICLE, "THE EFFICACY AND SAFETY OF DUODENAL STENTING: A PROSPECTIVE MULTICENTER STUDY" PUBLISHED IN ENDOSCOPY 2007; 39:784-787. THE FOLLOWING INFO WAS DERIVED FROM THIS ARTICLE: A WALLSTENT ENTERAL ENDOPROSTHESIS STENT WAS USED FOR A GASTRODUODENAL STENTING PROCEDURE (PT AGE, GENDER, AND WEIGHT UNK). ACCORDING TO THE ARTICLE, THE PT DEVELOPED DELAYED STENT DYSFUNCTION, BECAUSE OF OBSTRUCTION OF THE LUMEN, BY TUMOR INGROWTH. THERE IS NO FURTHER INFO FROM THE ARTICLE REGARDING THE STATUS OF THE PT.

    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 UNK Other