BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1213725 · Received October 22, 2008

    Report

    Report Number
    2134265-2008-03093
    Event Type
    Malfunction
    Date Received
    October 22, 2008
    Date of Event
    September 24, 2008
    Report Date
    September 24, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, STENT DAMAGE OCCURRED. THE PHYSICIAN ATTEMPTED TO CROSS THE LESION WITH A TAXUS EXPRESS2 2.5X20MM DRUG ELUTING STENT IN AN UNSPECIFIED VESSEL. THE STENT DELIVERY SYSTEM WAS UNABLE TO CROSS THE LESION. THE DISTAL PORTION OF THE STENT WAS LIFTED UP. THE PROCEDURE WAS COMPLETED WITH ANOTHER TAXUS EXPRESS2 STENT. NO PT COMPLICATIONS OCCURRED. PT STATUS IS SATISFACTORY.

    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 2.5X20MM 11574833

    Patients

    Seq Age Sex Outcome Treatment
    1