BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS (TM) LIBERTÉ (TM)

    MDR report key: 2162332 · Received July 14, 2011

    Report

    Report Number
    2134265-2011-02589
    Event Type
    Malfunction
    Date Received
    July 14, 2011
    Date of Event
    April 22, 2011
    Report Date
    April 25, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MFR: RETURNED PRODUCT CONSISTED OF A TAXUS LIBERTE STENT DELIVERY SYSTEM. BLOOD AND CONTRAST WERE IN THE DISTAL AND MIDSHAFT OF THE DEVICE WHICH IS CONSISTENT WITH THE REPORTED INFORMATION THAT THE DEVICE WAS USED. IT WAS DETERMINED THAT THE LAST TWO ROWS OF DISTAL STRUTS WERE STRETCHED AND FLARED. 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).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE TARGET LESION BEING TREATED WAS THE LEFT ANTERIOR DESCENDING ARTERY HOWEVER ADDITIONAL FOLLOW UP INDICATED THAT THE LESION LOCATION WAS IN THE LEFT MAIN CORONARY ARTERY (LMCA). THE 16X2.25MM TAXUS LIBERTE SDS WAS ADVANCED TO THE LMCA AND WAS UNABLE TO CROSS THE LESION.

    Description of Event or Problem · 1

    SAME CASE AS MDR ID: 2134265-2011-02751. THIS COMPLAINT IS NOW REPORTABLE BASED ON THE ANALYSIS COMPLETED ON (B)(6) 2011. IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE THE STENT WOULD NOT CROSS THE LESION. THE TARGET LESION BEING TREATED WAS LOCATED IN THE SEVERELY CALCIFIED AND TORTUOUS LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 12X2.25MM TAXUS LIBERTE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO A LESION IN THE LEFT MAIN CORONARY ARTERY AND WAS UNABLE TO CROSS THE LESION. A 16X2.25MM TAXUS LIBERTE SDS WAS ADVANCED TO THE LAD AND WAS ALSO UNABLE TO CROSS THE LESION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS STABLE. HOWEVER, THE RETURNED PRODUCT ANALYSIS REVEALED STENT DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS (TM) LIBERTÉ (TM) CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493894016220 0013663840

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR