BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVANIX¿ BILIARY STENT WITH NAVIFLEX¿ RX DELIVERY SYSTEM

    MDR report key: 2182974 · Received July 28, 2011

    Report

    Report Number
    3005099803-2011-02483
    Event Type
    Injury
    Date Received
    July 28, 2011
    Report Date
    July 7, 2011
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FGE
    PMA / PMN Number
    K101314
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT DATE: THE EXACT EVENT DATE IS UNKNOWN, HOWEVER IT WAS REPORTED THAT THE EVENT OCCURRED WITHIN 2 TO 3 WEEKS OF (B)(6), 2011.

    Additional Manufacturer Narrative · 1

    THE PATIENT'S EXACT AGE IS UNKNOWN, BUT IS REPORTEDLY (B)(6). 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

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX STENT PART OF AN ADVANIX¿ BILIARY STENT WITH NAVIFLEX RX DELIVERY SYSTEM WAS SCHEDULED FOR REMOVAL AFTER APPROXIMATELY 6WK OF BEING IMPLANTED IN THE DUODENUM OF A PATIENT (PATIENT AGE, SEX, AND WEIGHT ARE UNKNOWN). AS THE STENT WAS REMOVED FROM THE PATIENT WITH A SNARE, THE SNARE SLICED THROUGH THE STENT AND THE STENT TORE INTO TWO PIECES. ALL STENT FRAGMENTS WERE REMOVED FROM THE PATIENT AND NO FRAGMENTS WERE LEFT IN THE PATIENT. THE STENT REMOVAL PROCEDURE WAS COMPLETED WITH NO REPORTED PATIENT COMPLICATIONS. THE PATIENT WAS REPORTED TO BE FINE AFTER THE PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX STENT PART OF AN ADVANIX "BILIARY STENT WITH NAVIFLEX" RX DELIVERY SYSTEM WAS SCHEDULED FOR REMOVAL AFTER APPROXIMATELY (B)(6) OF BEING IMPLANTED IN THE DUODENUM OF A PATIENT (PATIENT AGE, SEX, AND WEIGHT ARE UNKNOWN). AS THE STENT WAS REMOVED FROM THE PATIENT WITH A SNARE, THE SNARE SLICED THROUGH THE STENT AND THE STENT TORE INTO TWO PIECES. ALL STENT FRAGMENTS WERE REMOVED FROM THE PATIENT AND NO FRAGMENTS WERE LEFT IN THE PATIENT. THE STENT REMOVAL PROCEDURE WAS COMPLETED 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 M00534300

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention