BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1083444 · Received July 29, 2008

    Report

    Report Number
    2134265-2008-02117
    Event Type
    Injury
    Date Received
    July 29, 2008
    Report Date
    June 29, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    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 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 INFO FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, LATE STENT MALAPPOSITION OCCURRED. A TAXUS EXPRESS2 DRUG ELUTING STENT WAS PLACED IN THE LEFT ANTERIOR DESCENDING ARTERY IN 2007. APPROX 9 MONTHS LATER, THE PT PRESENTED WITH UNSTABLE ANGINA. "TESTS WERE RUN AND IT APPEARS THAT THE VESSEL IS GROWING AWAY FROM THE STENT." IT IS FELT THAT IT IS NOT AN ANEURYSM AND THERE WAS NO ISSUE NOTED WITH THE STENT. THE PT WAS INSTRUCTED TO REMAIN ON PLAVIX AND PLAN TO DO A FOLLOW-UP ANGIOGRAM IN A YEAR. NO FURTHER INFO WAS AVAILABLE AT THE TIME OF THE REPORT.

    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 Other