BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1162097 · Received September 16, 2008

    Report

    Report Number
    2134265-2008-02662
    Event Type
    Injury
    Date Received
    September 16, 2008
    Report Date
    August 22, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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, THE PT DEVELOPED A RASH. THE TAXUS EXPRESS2 4.0X12MM DRUG ELUTING STENT WAS IMPLANTED IN THE RIGHT CORONARY ARTERY. ABOUT 20-30 DAYS LATER, THE PT PRESENTED WITH AN "AGGRESSIVE" RASH UNDER THE ARMS AND THE SKIN WAS VERY IRRITATED. THE PT HAD BEEN STARTED ON PLAVIX POST PROCEDURE AND WAS ALSO ON A NUMBER OF OTHER MEDICATIONS. SOME MEDICATIONS CHANGES WERE ALSO MADE AT THE TIME OF IMPLANT. THE PT WAS SEEN BY A DERMATOLOGIST, WHO STARTED THE PT ON STEROIDS, WHICH SEEMED TO BE EFFECTIVE. THE CARDIOLOGIST IS UNABLE TO DETERMINE THE RELATIONSHIP OF THE PT'S RASH TO THE TAXUS EXPRESS2 STENT OR IF IT COULD BE MEDICATION RELATED. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED.

    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 4.0X12MM

    Patients

    Seq Age Sex Outcome Treatment
    1 Other