BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVANIX¿ BILIARY STENT WITH NAVIFLEX¿ RX DELIVERY SYSTEM

    MDR report key: 2192007 · Received August 4, 2011

    Report

    Report Number
    3005099803-2011-02592
    Event Type
    Injury
    Date Received
    August 4, 2011
    Date of Event
    July 14, 2011
    Report Date
    July 14, 2011
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FGE
    PMA / PMN Number
    K101314
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX' BILIARY STENT WITH NAVIFLEX' RX DELIVERY SYSTEM WAS REMOVED DURING AN ERCP (ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY) FOLLOW-UP PROCEDURE IN THE BILE DUCT OF A (B)(6) OLD FEMALE PATIENT (PATIENT WEIGHT IS UNKNOWN). DURING POST PROCEDURE FOLLOW-UP, THE IMPLANTED ADVANIX BILIARY STENT, WHICH WAS PLACED A COUPLE MONTHS AGO, WAS NOTED TO HAVE PARTIALLY MIGRATED OUT OF THE BILE DUCT. THE 10 X 17 WILSON COOK BILIARY STENT ALSO IMPLANTED ALONGSIDE THE ADVANIX BILIARY STENT, ALSO PARTIALLY MIGRATED OUT OF THE BILE DUCT. THE MIGRATED STENTS DID NOT CAUSE ANY DAMAGE TO THE OPPOSITE WALL OF THE DUODENUM. THE MIGRATED ADVANIX BILIARY STENT WAS REMOVED AND A WILSON COOK STENT WAS IMPLANTED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO REPORTED PATIENT COMPLICATIONS. THE PATIENT WAS REPORTED TO BE FINE AFTER THE PROCEDURE.

    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 M00534730

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention