BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS (R) LIBERTÉ (R)

    MDR report key: 2254163 · Received September 19, 2011

    Report

    Report Number
    2134265-2011-04039
    Event Type
    Malfunction
    Date Received
    September 19, 2011
    Date of Event
    August 30, 2011
    Report Date
    August 30, 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 COMBINATION PRODUCT.DEVICE EVALUATED BY MANUFACTURER: 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

    SAME CASE AS MDR 2134265-2011-04038.IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE STENT DAMAGE OCCURRED.THE 90% STENOSED LESION BEING TREATED WAS LOCATED IN THE MODERATELY TORTUOUS RIGHT CORONARY ARTERY WITH 90-120 DEGREE CALCIFICATION. THE PHYSICIAN ADVANCED THE 24 X 2.75MM TAXUS LIBERTE STENT DELIVERY SYSTEM (SDS) TO THE TARGET LESION, HOWEVER THE SDS FAILED TO CROSS THE LESION. UPON REMOVAL IT WAS NOTED THAT STENT DAMAGE OCCURRED. THEN THE PHYSICIAN ADVANCED THE 28 X 2.75MM TAXUS LIBERTE SDS TO THE TARGET LESION, HOWEVER IT ALSO FAILED TO CROSS THE LESION. UPON REMOVAL IT WAS NOTED THAT STENT DAMAGE OCCURRED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. 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 (R) LIBERTÉ (R) CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493893628270 13347451

    Patients

    Seq Age Sex Outcome Treatment
    1 TAXUS LIBERTE STENT 24 X 2.75MM