BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS (R) LIBERTÉ (R)

    MDR report key: 2231762 · Received September 1, 2011

    Report

    Report Number
    2134265-2011-03716
    Event Type
    Malfunction
    Date Received
    September 1, 2011
    Date of Event
    August 9, 2011
    Report Date
    August 10, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. DEVICE IS COMBINATION PRODUCT. DEVICE EVALUATED BY MFR.: THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL/PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION STENT DAMAGE OCCURRED. THE 99% STENOSED LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED MID RIGHT CORONARY ARTERY. THE 3.5 X 32MM TAXUS LIBERTE (MR) STENT DELIVERY SYSTEM WAS ADVANCED, BUT WAS UNABLE TO CROSS THE LESION DUE TO THE SEVERELY CALCIFIED LESION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENTS' STATUS WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS (R) LIBERTÉ (R) CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493893632350 13967919

    Patients

    Seq Age Sex Outcome Treatment
    1