BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANIX¿ BILIARY STENT WITH NAVIFLEX¿ RX DELIVERY SYSTEM

    MDR report key: 2051079 · Received April 12, 2011

    Report

    Report Number
    3005099803-2011-01216
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Date of Event
    March 22, 2011
    Report Date
    March 22, 2011
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FGE
    PMA / PMN Number
    K101314
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SE
    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) RELATES TO (B)(4) FOR THE ISSUE OF STENT POSITIONING ISSUE. THE COMPLAINANT INDICATED THAT THE DEVICE WAS IMPLANTED; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CAN 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 A PRELOADED ADVANIX RX BILIARY STENT SYSTEM WAS USED DURING AN ERCP (ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY) PROCEDURE IN THE COMMON BILE DUCT OF A (B)(6) MALE PATIENT (PATIENT WEIGHT IS UNKNOWN). DURING THE PROCEDURE, A 7FR X 15CM FLEXIMA BILIARY STENT AND AN 8.5FR X 15CM ADVANIX BILIARY STENT WERE IMPLANTED. AS THE PHYSICIAN ATTEMPTED TO IMPLANT A THIRD STENT, AN 8.5FR X 15CM ADVANIX BILIARY STENT, THE ALREADY IMPLANTED ADVANIX RX BILIARY STENT WAS INADVERTENTLY PUSHED FATHER IN TO THE DUCT. THE PHYSICIAN USED FORCEPS TO REPOSITION THIS STENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ALL STENTS REMAINING IN THE PATIENT. THERE WERE NO REPORTED PATIENT COMPLICATIONS. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION 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 M00534660

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR