BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1181141 · Received September 30, 2008

    Report

    Report Number
    2134265-2008-02834
    Event Type
    Injury
    Date Received
    September 30, 2008
    Report Date
    September 2, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVAL; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A LABELING REVIEW IDENTIFIED THAT THE DEVICE WAS USED AS PER THE DIRECTIONS FOR USE (DFU) FOR TAXUS EXPRESS2. THE MFG RECORDS HAVE BEEN REVIEWED AND NO ISSUES OR DISCREPANCIES WERE FOUND. THE MOST PROBABLE ROOT CAUSE FOR THIS EVENT IS ANTICIPATED PROCEDURAL COMPLICATION AS THE DEVICE RELATED ROOT CAUSE DOES NOT APPLY AND THE COMPLAINT IS DUE TO A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE NOTED WITHIN THE DFU, AND/OR DEVICE LABELING.

    Description of Event or Problem · 1

    SAME AS MFR #2134265-2008-02833. IT WAS REPORTED THAT POST A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE THAT STENT THROMBOSIS OCCURRED. THE PHYSICIAN IMPLANTED TWO TAXUS EXPRESS2 SIZES 3.50X24MM AND 3.50X20MM DRUG ELUTING STENTS IN AN UNSPECIFIED LOCATION. POST PROCEDURE STENT-THROMBOSIS AND MYOCARDIAL INFARCTION OCCURRED. ADDITIONAL INFO HAS BEEN REQUESTED BUT NOT RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM NIQ STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC CORPORATION 3.50X20MM 8693334

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention