BEUDAMED
    FDA Adverse Event Death Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 2100895 · Received May 24, 2011

    Report

    Report Number
    2134265-2011-01924
    Event Type
    Death
    Date Received
    May 24, 2011
    Date of Event
    April 23, 2011
    Report Date
    April 26, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A 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

    IT WAS REPORTED THAT POST A STENTING TREATMENT PROCEDURE, A PATIENT DEATH OCCURRED. THE 80% STENOSED, 3.0X35MM CONCENTRIC DE NOVO LESION BEING TREATED CONTAINED A >45 DEGREE AND <90 DEGREE BEND AND WAS LOCATED IN THE NON-TORTUOUS, MILD TO SEVERELY CALCIFIED PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE LESION WAS PREDILATED WITH AN UNSPECIFIED BALLOON AND THE PHYSICIAN DEPLOYED A 3.0X38MM TAXUS LIBERTE STENT. THE STENT WAS WELL APPOSED. MEDICATIONS GIVEN: CLOPIDOGREL, ASPIRIN, AND EPTIFIBATIDE. THREE DAYS POST THE STENTING PROCEDURE, THE PATIENT EXPERIENCE CHEST PAIN. IN-STENT THROMBOSIS WAS IDENTIFIED IN THE PREVIOUSLY IMPLANTED STENT. A NON-BSC CATHETER WAS USED TO REMOVE THE THROMBUS. PATIENT DEATH OCCURRED THE SAME DAY.

    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 - GALWAY H7493894038300 0013412986

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Death