BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1841362 · Received September 22, 2010

    Report

    Report Number
    2134265-2010-04160
    Event Type
    Malfunction
    Date Received
    September 22, 2010
    Date of Event
    September 2, 2010
    Report Date
    September 2, 2010
    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 EVALUATED BY MANUFACTURER - AS A DEVICE HAS NOT BEEN RETURNED, A TECHNICAL ANALYSIS CANNOT BE PERFORMED. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE CLASSIFICATION 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. ACCESS WAS OBTAINED VIA THE FEMORAL ARTERY. THE LESION WAS LOCATED IN AN UNSPECIFIED ARTERY. A 2.5X32MM TAXUS LIBERTE' STENT WAS ADVANCED TO THE LESION AND COULD NOT CROSS. WHEN THE DEVICE WAS REMOVED FROM THE PATIENT, STENT DAMAGE WAS NOTED. THE PROCEDURE WAS COMPLETED WITH AN UNKNOWN STENT. NO PATIENT COMPLICATIONS WERE REPORTED. PATIENT STATUS IS LISTED AS GOOD. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE.

    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 H7493893632250 13053965

    Patients

    Seq Age Sex Outcome Treatment
    1