BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXIMA BILIARY STENT SYSTEM

    MDR report key: 1161294 · Received September 15, 2008

    Report

    Report Number
    3005099803-2008-04571
    Event Type
    Injury
    Date Received
    September 15, 2008
    Date of Event
    August 21, 2008
    Report Date
    August 21, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    FGE
    PMA / PMN Number
    K965147
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A HEPATIC DUCT STENTING TREATMENT PROCEDURE SHEATH DETACHMENT AND STENT EXPLANTATION OCCURRED. THE TARGET LESIONS WERE IN THE LEFT AND RIGHT HEPATIC DUCT. UNSPECIFIED TYPES OF GUIDE WIRES WERE ADVANCED INTO THE LEFT AND RIGHT COMMON HEPATIC DUCT. AN 8.5FR/12CM FLEXIMA BILIARY STENT WAS IMPLANTED IN THE RIGHT COMMON HEPATIC DUCT; HOWEVER, THE INNER SHEATH ALSO DETACHED AND WAS "LEFT INSIDE THE STENT". THE PHYSICIAN SUCCESSFULLY IMPLANTED AN UNSPECIFIED TYPE OF STENT IN THE LEFT COMMON HEPATIC DUCT. THE PREVIOUSLY IMPLANTED 8.5FR/12CM FLEXIMA BILIARY STENT WAS EXPLANTED AND REPLACED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. THE PATIENT'S CURRENT CONDITION IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXIMA BILIARY STENT SYSTEM FGE BOSTON SCIENTIFIC M00539280 117116265

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R