BEUDAMED
    FDA Adverse Event Death Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1713768 · Received June 8, 2010

    Report

    Report Number
    2134265-2010-02460
    Event Type
    Death
    Date Received
    June 8, 2010
    Date of Event
    May 9, 2010
    Report Date
    May 11, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER - AS A UNIT HAS NOT BEEN RETURNED, A TECHNICAL ANALYSIS CANNOT BE PERFORMED. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE CLASSIFICATION IS ANTICIPATED PROCEDURAL COMPLICATIONS AS THIS EVENT IS A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE AND IS NOTED WITHIN THE DFU. (B) (4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, A PATIENT DEATH OCCURRED. THE PATIENT PRESENTED WITH RECURRENT ANGINA. THE LESION WAS AN 80% STENOSED CONCENTRIC IN-STENT RESTENOSIS OF A BARE METAL STENT PLACED IN A MILDLY TORTUOUS AND NON-CALCIFIED PROXIMAL LEFT ANTERIOR DESCENDING ARTERY APPROXIMATELY 9 YEARS PRIOR. ACCESS WAS FEMORAL. A 3.5X16MM TAXUS LIBERTE¿ DRUG ELUTING STENT WAS DEPLOYED AT 14 ATMS FOR 43 SECONDS WITHIN THE PREVIOUSLY PLACED STENT EXTENDING INTO THE PROXIMAL PORTION OF THE ARTERY. NO PATIENT INJURIES OR COMPLICATIONS OCCURRED. THE PATIENT COMPLAINED OF INDIGESTION PRIOR TO DISCHARGE. ANTIPLATELET THERAPY OF PLAVIX AND ASPIRIN WERE PRESCRIBED. TWO DAYS POST PROCEDURE, THE PATIENT EXPIRED. CAUSE OF DEATH IS LISTED AS SUDDEN CARDIAC ARREST.

    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 H7493893616350 12701782

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Death JL4 CORDIS 6F GUIDE CATHETER| LUGE GUIDEWIRE