BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALLSTENT ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM

    MDR report key: 1190619 · Received October 6, 2008

    Report

    Report Number
    2134265-2008-02913
    Event Type
    Malfunction
    Date Received
    October 6, 2008
    Date of Event
    August 14, 2000
    Report Date
    September 9, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    FGE
    PMA / PMN Number
    K993232
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNSPECIFIED STENTING PROCEDURE, THE STENT PARTIALLY DEPLOYED. THE ANATOMY LOCATION, VESSEL AND LESION LOCATION ARE UNKNOWN. THE 10X20X75/6F UNISTEP PLUS STENT DELIVERY SYSTEM (SDS) WAS INTRODUCED, BUT NOT ADVANCED TO THE LESION. THE PHYSICIAN DECIDED TO REMOVE THE SDS FOR UNSPECIFIED REASONS. AFTER WITHDRAWAL FROM THE PATIENT, IT WAS OBSERVED THAT THE STENT WAS PARTIALLY DEPLOYED BUT REMAINED ATTACHED TO THE SDS. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT INJURIES OR COMPLICATIONS WERE REPORTED. THE PATIENT'S CONDITION WAS REPORTED AS "FINE." IT WAS FURTHER NOTED THAT AFTER THE PROCEDURE, WHEN PREPARING THE DEVICE FOR RETURN, THE STENT NO LONGER REMAINED ATTACHED TO THE SDS AND COULD NOT BE LOCATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WALLSTENT ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM FGE CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC NA 9446760

    Patients

    Seq Age Sex Outcome Treatment
    1