BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS LIBERTE' PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1234056 · Received November 4, 2008

    Report

    Report Number
    2134265-2008-04213
    Event Type
    Malfunction
    Date Received
    November 4, 2008
    Date of Event
    October 10, 2008
    Report Date
    October 13, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS #2134265-2008-04212. IT WAS REPORTED THAT DURING PREPARATION FOR A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, STENT DAMAGE WAS NOTED. WHEN THE TAXUS LIBERTE' 2.75X38MM DRUG ELUTING STENT WAS REMOVED FROM THE PACKAGE, IT WAS FOUND TO BE CRUSHED. AS THERE WAS NO PATIENT INVOLVEMENT, NO PATIENT COMPLICATIONS OCCURRED. PATIENT 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 2.75X38MM 11652186

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR