BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPRESS BILIARY LD PREMOUNTED STENT SYSTEM

    MDR report key: 1051690 · Received May 19, 2008

    Report

    Report Number
    2134265-2008-01439
    Event Type
    Malfunction
    Date Received
    May 19, 2008
    Date of Event
    April 22, 2008
    Report Date
    April 22, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    FGE
    PMA / PMN Number
    K021630
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, ADVANCEMENT DIFFICULTIES AND A STENT DISLODGEMENT OCCURRED. THE LESION WAS LOCATED IN THE LEFT ILIAC ARTERY, HOWEVER, THE PERCENT OF THE STENOSIS OF THE LESION, DEGREE OF CALCIFICATION, AND VESSEL TORTUOSITY ARE UNKNOWN. UPON INSERTING, THE EXPRESS BILIARY 10.0MM X 30MM X 75CM STENT DELIVERY SYSTEM INTO AN UNSPECIFIED SHEATH, THE CATHETER BECAME STUCK AND WAS UNABLE TO BE REMOVED. THE PHYSICIAN REMOVED THE STENT DELIVERY SYSTEM AND SHEATH AS A UNIT. UPON INSPECTION, IT WAS NOTED THAT STENT HAD DISLODGED FROM THE STENT DELIVERY SYSTEM BUT REMAINED ON THE DEVICE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT INJURIES OR COMPLICATIONS WERE REPORTED. THE PATIENT'S STATUS IS REPORTED AS "FINE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXPRESS BILIARY LD PREMOUNTED STENT SYSTEM FGE CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC NA 11414701

    Patients

    Seq Age Sex Outcome Treatment
    1