BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXPRESS BILIARY SD MONORAIL PREMOUNTED STENT SYSTEM

    MDR report key: 1080399 · Received July 22, 2008

    Report

    Report Number
    2134265-2008-02039
    Event Type
    Injury
    Date Received
    July 22, 2008
    Date of Event
    June 25, 2008
    Report Date
    June 25, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    FGE
    PMA / PMN Number
    K040027
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ABDOMINAL CELIAC ANGIOGRAM AND SUBSEQUENT RENAL STENTING PROCEDURE, A STENT DISLODGEMENT OCCURRED. THE TARGETED LESION WAS IN THE CELIAC ARTERY; THE SEGMENT OF VESSEL AND LESION CHARACTERISTICS IS UNK. THE 6.0MM X 18MM EXPRESS STENT DELIVERY SYSTEM WAS ADVANCED VIA ANOTHER MFR'S 6F SHEATH. IT WAS REPORTED THAT THE STENT DISLODGED FROM THE DELIVERY DEVICE PRIOR TO DEPLOYMENT, NOTING THAT "THE BALLOON HAD NOT BEEN INFLATED". NEXT, THE PHYSICIAN PERFORMED A CUTDOWN PROCEDURE AND THE STENT WAS RETRIEVED INTACT. THE PT'S CONDITION WAS REPORTED AS "PT IS DOING GOOD".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXPRESS BILIARY SD MONORAIL PREMOUNTED STENT SYSTEM FGE CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC NA 11475101

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention