BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANIX¿ BILIARY STENT WITH NAVIFLEX¿ RX DELIVERY SYSTEM

    MDR report key: 2122389 · Received June 13, 2011

    Report

    Report Number
    3005099803-2011-02004
    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. 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 TWO DEVICES USED DURING THE SAME PROCEDURE. MANUFACTURER REPORT # 3005099803-2011-02003 AND 3005099803-2011-02004 ADDRESS THESE DEVICES. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO 10FR X 9CM ADVANIX STENTS BILIARY STENTS WAS REMOVED DURING A SCHEDULED STENT REMOVAL PROCEDURE OF A PATIENT (PATIENT AGE, SEX, WEIGHT, AND EVENT DATE ARE UNKNOWN). UPON REMOVAL OF BOTH STENT, THE PHYSICIAN NOTED A CRIMP ON THE STENT. THERE WERE NO KNOWN PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NO ADDITIONAL DETAILS REGARDING THE EVENT DESCRIPTION OR PATIENT CONDITION IS AVAILABLE.

    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