BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 2031994 · Received March 28, 2011

    Report

    Report Number
    2134265-2011-00922
    Event Type
    Malfunction
    Date Received
    March 28, 2011
    Date of Event
    March 10, 2011
    Report Date
    March 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

    (B)(4) DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MANUFACTURER - THE COMPLAINT DEVICE WAS NOT RECEIVED 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 STENTING TREATMENT PROCEDURE, STENT DAMAGE OCCURRED. THE ECCENTRIC LESION BEING TREATED CONTAINED A <= 45 DEGREE BEND AND WAS LOCATED IN THE MODERATELY TORTUOUS RIGHT CORONARY ARTERY (RCA). THE PHYSICIAN ATTEMPTED TO PLACE THE 3.00X16MM TAXUS LIBERTE STENT, BUT WAS UNABLE TO CROSS THE LESION. WHEN REMOVED FROM THE BODY, THE STENT WAS FOUND TO BE FLARED. THE PROCEDURE WAS COMPLETED WITH ANOTHER 3.00X16MM TAXUS LIBERTE STENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493893616300 13864152

    Patients

    Seq Age Sex Outcome Treatment
    1 RUNTHROUGH NS GUIDE WIRE| MACH1 6F FR3.5 GUIDE CATHETER