BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANIX¿ BILIARY STENT WITH NAVIFLEX¿ RX DELIVERY SYSTEM

    MDR report key: 2122152 · Received June 13, 2011

    Report

    Report Number
    3005099803-2011-02027
    Event Type
    Malfunction
    Date Received
    June 13, 2011
    Report Date
    May 23, 2011
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FGE
    PMA / PMN Number
    K101314
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO PROVIDE THE DEVICE LOT NUMBER; THEREFORE, THE DEVICE MANUFACTURE DATE AND EXPIRATION DATE ARE UNKNOWN. ALTHOUGH THE LOT NUMBER IS UNKNOWN, THE COMPLAINANT REPORTED THAT THE DEVICE WAS NOT USED PAST THE EXPIRATION DATE. (B)(4). THE COMPLAINANT INDICATED THAT THE DEVICE HAS BEEN DISPOSED; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF FOUR DEVICES USED DURING THE SAME PROCEDURE. MANUFACTURER REPORT # 3005099803-2011-02024, 3005099803-2011-02025, 3005099803-2011-02026, AND 3005099803-2011-02027 ADDRESS THESE DEVICES. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT FOUR 10FR X 9CM ADVANIX STENTS BILIARY STENTS WAS REMOVED FROM THE COMMON BILE DUCT DURING A SCHEDULED STENT REMOVAL PROCEDURE OF A PATIENT (PATIENT AGE, SEX,WEIGHT, AND EVENT DATE ARE UNKNOWN). DURING THE REMOVAL PROCEDURE, THE FIRST THREE STENTS WERE REMOVED WITH A SNARE AND THE STENTS STRETCHED UPON REMOVAL. UPON REMOVAL OF THE FOURTH STENT, THE STENT BROKE IN TWO PIECES. IN THE CASE WHERE THE STENT BROKE IN TWO PIECES (MANUFACTURER REPORT # 3005099803-2011-02026), ALL STENT FRAGMENTS WERE REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH NO REPORTED PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVANIX¿ BILIARY STENT WITH NAVIFLEX¿ RX DELIVERY SYSTEM BILIARY CATHETERS AND ACCESSORIES FGE BOSTON SCIENTIFIC - SPENCER M00533370

    Patients

    Seq Age Sex Outcome Treatment
    1