BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1153346 · Received September 5, 2008

    Report

    Report Number
    2134265-2008-02536
    Event Type
    Injury
    Date Received
    September 5, 2008
    Report Date
    August 12, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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'S WIFE, THAT POST A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, HYPERSENSITIVITY OCCURRED. THE PHYSICIAN IMPLANTED A TAXUS EXPRESS2 DRUG ELUTING STENT, UNK SIZE, TO AN UNK VESSEL. THE PT WAS DISCHARGED THREE DAYS POST PROCEDURE. THE PT WAS THEN READMITTED TO THE HOSPITAL WITH ADDITIONAL PROBLEMS THAT THEY THINK MAY BE DUE TO "INFLAMMATION TO THE HEART." TEST RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. THE PT ALSO HAS SENSITIVITY TO METALS AND SUFFERS CONTACT ECZEMA. NO ADDITIONAL INFO REGARDING THIS EVENT IS AVAILABLE.

    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