BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1192132 · Received October 7, 2008

    Report

    Report Number
    2134265-2008-02928
    Event Type
    Injury
    Date Received
    October 7, 2008
    Report Date
    September 15, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PATIENT

    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 BY THE PT THAT POST A CORONARY STENTING TREATMENT PROCEDURE THE PT EXPERIENCED A FEVER AND WAS HOSPITALIZED. A TAXUS EXPRESS2 DRUG ELUTING STENT (DES) OF UNKNOWN SIZE WAS IMPLANTED IN THE PT AND IT WAS NOTED THAT SINCE THE DEVICE IMPLANTATION THE PT HAS "NOT BEEN WELL". THE DAY FOLLOWING THE PROCEDURE THE PT BEGAN EXPERIENCING CHILLS THREE TO FOUR TIMES A DAY. ALMOST TWO MONTHS AFTER THE TAXUS EXPRESS2 DES WAS IMPLANTED THE PT WAS HOSPITALIZED WITH A 103 DEGREE FEVER OF UNKNOWN ORIGIN. THE PT WAS TREATED WITH ANTIBIOTICS AND FEVER WAS RESOLVED. IT WAS ALSO NOTED THAT RIGHT AFTER STENT IMPLANTATION THE PT DEVELOPED A "DULL PAIN" ON THE UPPER LEFT SIDE OF HER CHEST. FOLLOW UP WITH THE PHYSICIAN INDICATED THAT THE PHYSICIAN WAS UNAWARE OF THE PATIENT'S CONDITION. THE PHYSICIAN WAS UNABLE TO PROVIDE ANY ADDITIONAL INFO.

    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 Hospitalization