BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1192125 · Received October 7, 2008

    Report

    Report Number
    2134265-2008-02917
    Event Type
    Injury
    Date Received
    October 7, 2008
    Date of Event
    August 27, 2008
    Report Date
    September 22, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    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. AS THE BATCH NUMBER IS UNKNOWN A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE CARRIED OUT. THE ROOT CAUSE WILL BE DOCUMENTED AS ANTICIPATED PROCEDURAL COMPLICATION DUE TO A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE NOTED WITHIN THE DIRECTIONS FOR USE, AND/OR DEVICE LABELING.

    Description of Event or Problem · 1

    IT WAS REPORTED, BY THE PT, THAT POST A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, PAIN, MI AND BLOCKAGE OCCURRED. THE PHYSICIAN IMPLANTED A TAXUS EXPRESS2 DRUG ELUTING STENT, UNKNOWN SIZE, TO THE RIGHT CORONARY ARTERY (RCA). IMMEDIATELY POST STENT IMPLANTATION THE PT EXPERIENCED "STENT PAIN" ON A REGULAR BASIS. THREE YEARS AND SIX MONTHS POST PROCEDURE THE PT EXPERIENCED A "MASSIVE MI" FROM THE RCA BEING 100% BLOCKED AND HAD THREE NON BSC STENTS PLACED. ADDITIONAL INFO REGARDING THIS EVENT HAS BEEN REQUESTED, BUT IS NOT AVAILABLE.

    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

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention