BEUDAMED
    FDA Adverse Event Death Summary report: N

    TAXUS® LIBERTÉ®

    MDR report key: 3042241 · Received April 9, 2013

    Report

    Report Number
    2134265-2013-02132
    Event Type
    Death
    Date Received
    April 9, 2013
    Date of Event
    February 21, 2013
    Report Date
    March 11, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS COMBINATION PRODUCT. DEVICE EVALUATION 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 ID# 2134265-2013-02133. (B)(4). IT WAS REPORTED THAT POST A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE, THE PATIENT EXPERIENCED CARDIAC ARREST AND EXPIRED. ON (B)(6) 2010, THE PATIENT PRESENTED DUE TO UNSTABLE ANGINA AND POSITIVE STRESS TEST. A 20X3.50MM TAXUS LIBERTE STUDY STENT WAS PLACED IN THE PROXIMAL RIGHT CORONARY ARTERY AND A 32X2.5MM TAXUS LIBERTE STUDY STENT WAS PLACED IN THE THIRD OBTUSE MARGINAL BRANCH SEGMENT, RESULTING IN 0% RESIDUAL STENOSIS WITH TIMI 3 FLOW AT BOTH SEGMENTS. THE FOLLOWING DAY THE PATIENT WAS DISCHARGED ON ASPIRIN. IN (B)(6) 2013, THAT PATIENT EXPERIENCED CARDIAC ARREST. THE PATIENT WAS FOUND UNRESPONSIVE, CPR WAS INITIATED BY EMERGENCY MEDICAL SERVICE AND THE PATIENT RECEIVED DEFIBRILLATION FOR 30 MINUTES. AN ECHOCARDIOGRAM REVEALED LEFT VENTRICULAR HYPERTROPHY WITH NORMAL EJECTION FRACTION AND NO SEGMENTAL WALL MOTION ABNORMALITIES NOTED. THE PATIENT EXPIRED OF ARRHYTHMIA AND AN AUTOPSY WAS NOT PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    145342 TAXUS® LIBERTÉ® CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493893732250 12830660

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Death