BEUDAMED
    FDA Adverse Event Death Summary report: N

    ULTRAFLEX PRECISION COLONIC STENT SYSTEM

    MDR report key: 1328745 · Received February 27, 2009

    Report

    Report Number
    3005099803-2009-00844
    Event Type
    Death
    Date Received
    February 27, 2009
    Report Date
    January 30, 2009
    Manufacturer
    BOSTON SCIENTIFIC IRELAND, LTD.
    Product Code
    MQR
    PMA / PMN Number
    K030769
    Adverse Event
    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 AND DEATH ARE UNKNOWN. ON JANUARY 30, 2009, A BOSTON SCIENTIFIC CORPORATION EMPLOYEE BECAME AWARE OF A CLINICAL STUDY ARTICLE, "ULTRAFLEX PRECISION COLONIC STENT PLACEMENT AS A BRIDGE TO SURGERY IN PATIENTS WITH MALIGNANT COLON OBSTRUCTION BY D. FREGONESE, ET AL PUBLISHED IN GASTROINTESTINAL ENDOSCOPY; 2008, V. 67 , PAGES 68-73. ACCORDING TO THE ARTICLE, IN THIS PATIENT, A COLONIC TUMOR PERFORATION WAS NOTED AT THE TIME OF SURGERY PERFORMED SIX DAYS AFTER SEMS PLACEMENT. THE SEMS WAS SURGICALLY REMOVED, AND THE EVENT RESOLVED WITHOUT SEQUELAE. THE PATIENT LATER DIED OF SEPSIS. NO DIRECT RELATIONSHIP BETWEEN SEMS PLACEMENT AND THE DEVELOPMENT OF SEPSIS COULD BE CONFIRMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRAFLEX PRECISION COLONIC STENT SYSTEM MQR BOSTON SCIENTIFIC IRELAND, LTD. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death