BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1842615 · Received September 23, 2010

    Report

    Report Number
    2134265-2010-04123
    Event Type
    Malfunction
    Date Received
    September 23, 2010
    Date of Event
    August 25, 2010
    Report Date
    September 1, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORONARY ARTERY STENTING TREATMENT PROCEDURE STENT DAMAGE OCCURRED. THE LESION BEING TREATED WAS LOCATED IN THE ANTERIOR INTERVENTRICULAR ARTERY. THE PHYSICIAN PRE-DILATED THE LESION AND WAS ATTEMPTING TO IMPLANT TAXUS LIBERTE 2.25X24 STENT, HOWEVER IT WAS UNABLE TO CROSS THE LESION. WHEN THE STENT WAS WITHDRAWN STENT DAMAGE WAS OBSERVED ON THE PROXIMAL END OF THE STENT. THE PHYSICIAN THEN WAS ABLE TO CROSS THE LESION SUCCESSFULLY WITH A .25X24MM PROMUS ELEMENT STENT. THERE WERE NO REPORTED COMPLICATIONS AND THE PATIENT CONDITION IS LISTED AS O.K.

    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 - GALWAY H7493894024220 12936919

    Patients

    Seq Age Sex Outcome Treatment
    1 PROMUS ELEMENT 2.24X24MM STENT