BEUDAMED
    FDA Adverse Event Death Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 6000784 · Received October 5, 2016

    Report

    Report Number
    2134265-2016-09193
    Event Type
    Death
    Date Received
    October 5, 2016
    Report Date
    September 7, 2016
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. LITERATURE CITATION: NASU, K. ET AL. (2015). TWO-YEAR CLINICAL OUTCOME IN PATIENTS WITH SMALL CORONARY ARTERY DISEASE TREATED WITH EVEROLIMUS ¿ VERSUS PACLITAXEL ¿ ELUTING STENTING. JOURNAL OF CARDIOLOGY, 2016, (68) (3) P. 209-214. 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

    IT WAS REPORTED VIA A JOURNAL ARTICLE THAT PATIENTS EXPERIENCED ADVERSE EVENTS INCLUDING DEATH, MYOCARDIAL INFARCTION AND REINTERVENTION. TAXUS LIBERTE STENTS WERE USED IN SMALL CORONARY ARTERY VESSELS. NON-BSC STENTS WERE ALSO USED. WITHIN THE TAXUS LIBERTE GROUP EVENTS OF DEATH, MYOCARDIAL INFARCTION AND TARGET VESSEL REINTERVENTION WERE NOTED. THESE EVENTS WERE NOT LINKED TO SPECIFIC PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    652271 TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY UNK433

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| R