BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1181130 · Received September 30, 2008

    Report

    Report Number
    2134265-2008-02839
    Event Type
    Injury
    Date Received
    September 30, 2008
    Date of Event
    August 29, 2008
    Report Date
    September 2, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, 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, A THROMBOSIS OCCURRED. THE PHYSICIAN IMPLANTED A TAXUS EXPRESS2 DRUG ELUTING STENT, UNK SIZE, TO THE OSTIAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. APPROX THREE YEARS POST STENT IMPLANTATION, THE PT WAS TREATED FOR A THROMBOSIS. THE THROMBOSIS WAS BALLOONED AND ANOTHER STENT WAS PLACED DISTAL TO THE PREVIOUSLY PLACED STENT. THE PT HAD STOPPED TAKING PLAVIX ONE MONTH PRIOR TO THE THROMBOSIS. PT STATUS POST PROCEDURE IS NOTED AS FINE. ADDITIONAL INFO REGARDING THIS EVENT HAS BEEN REQUESTED.

    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 Required Intervention