BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS® LIBERTÉ® ATOM?

    MDR report key: 3903198 · Received June 30, 2014

    Report

    Report Number
    2134265-2014-03786
    Event Type
    Injury
    Date Received
    June 30, 2014
    Date of Event
    April 11, 2011
    Report Date
    June 5, 2014
    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

    DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MFR: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. 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

    (B)(4) TRIAL. IT WAS REPORTED THAT POST A CORONARY STENTING TREATMENT PROCEDURE THE PATIENT EXPERIENCED A POSSIBLE MYOCARDIAL INFARCTION. IN MARCH 2011, A 2.5X18MM PROMUS STENT AND A 2.25X20MM TAXUS LIBERTE STENT WERE PLACED. IN (B)(6) 2011 THE PATIENT EXPERIENCED RECURRENT ISCHEMIC SYMPTOMS LASTING 10 MINUTES OR MORE WITH A NEW ST ELEVATION, DEPRESSION OR BBB. CARDIAC ENZYMES, ECHOCARDIOGRAM AND ANGIOGRAPHY WERE PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380567 TAXUS® LIBERTÉ® ATOM? CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493893620220 13402163

    Patients

    Seq Age Sex Outcome Treatment
    1 Other