BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1895013 · Received November 10, 2010

    Report

    Report Number
    2134265-2010-04931
    Event Type
    Injury
    Date Received
    November 10, 2010
    Date of Event
    September 24, 2010
    Report Date
    October 13, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MFR. 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 FURTHER REPORTED THAT PATIENT UNDERWENT THE INDEX PROCEDURE DUE TO A POSITIVE STRESS TEST. CARDIAC CATHETERIZATION REVEALED A LESION IN THE MID LEFT ANTERIOR DESCENDING CORONARY ARTERY. A 3.0X16MM TAXUS LIBERTE STENT DELIVERY SYSTEM WAS ADVANCED AND DEPLOYED IN THE TARGET LESION, AT WHICH POINT AN UNKNOWN GRADE EDGE DISSECTION OCCURRED. IT WAS TREATED WITH PLACEMENT OF A 2.5X8MM TAXUS LIBERTE STENT RESULTING IN 0% RESIDUAL STENOSIS AND TIMI-3 FLOW. THE DISSECTION WAS REPORTED TO BE RESOLVED. THE PATIENT WAS DISCHARGED THE NEXT DAY ON CLOPIDOGREL.

    Description of Event or Problem · 1

    (B)(4). IT WAS REPORTED THAT DURING A CORONARY STENTING TREATMENT PROCEDURE, A VESSEL DISSECTION OCCURRED. AT THE INDEX PROCEDURE, AN UNKNOWN SIZE TAXUS LIBERTE STENT WAS IMPLANTED IN AN UNSPECIFIED VESSEL. IT WAS REPORTED THAT DURING THIS PROCEDURE, A VESSEL DISSECTION OCCURRED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND 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 H7493893616300 12976289

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other