BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1132611 · Received August 22, 2008

    Report

    Report Number
    2134265-2008-02421
    Event Type
    Injury
    Date Received
    August 22, 2008
    Date of Event
    July 17, 2008
    Report Date
    July 30, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE ANALYSIS. THE STENT REMAINS IMPLANTED. THE COMPLAINANT INDICATED THAT THE DELIVERY DEVICE WILL NOT BE RETURNED FOR EVAL; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE 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, AN ALLERGIC REACTION OCCURRED. A PHYSICIAN IMPLANTED AN UNKNOWN SIZE TAXUS EXPRESS2 DRUG ELUTING STENT IN AN UNSPECIFIED LOCATION. TWENTY DAYS LATER, THE PT PRESENTED AT A DIFFERENT FACILITY WITH A FEVER AND "ENTIRE FEELING OF HEAT." NO SKIN SYMPTOMS WERE OBSERVED, BUT AN ATTENDING PHYSICIAN FELT THAT THERE WAS A POSSIBILITY OF ALLERGIC REACTION TO THE TAXUS STENT. ADDITIONAL INFO WAS REQUESTED BUT WAS UNAVAILABLE.

    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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other