BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1203636 · Received October 16, 2008

    Report

    Report Number
    2134265-2008-03051
    Event Type
    Malfunction
    Date Received
    October 16, 2008
    Date of Event
    September 18, 2008
    Report Date
    September 18, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING CORONARY ARTERY DRUG ELUTING STENTING PROCEDURE, THE STENT WAS DAMAGED. THE PHYSICIAN INTRODUCED THE TAXUS LIBERTE DRUG ELUTING STENT, BUT WAS UNABLE TO CROSS THE LESION. THE STENT DELIVERY SYSTEM WAS REMOVED AND DAMAGE TO THE DISTAL PORTION OF THE STENT WAS NOTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WERE NO REPORTED PT COMPLICATIONS AND THE PT WAS REPORTED TO BE STABLE POST PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM NIQ - STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC CORPORATION 2.25X12MM 11686135

    Patients

    Seq Age Sex Outcome Treatment
    1