BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1011279 · Received March 11, 2008

    Report

    Report Number
    2134265-2008-00720
    Event Type
    Injury
    Date Received
    March 11, 2008
    Report Date
    February 20, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; 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 INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    B3: "APPROXIMATELY 2 MONTHS" FOLLOWING IMPLANT. IT WAS REPORTED THAT FOLLOWING A CORONARY ARTERY DRUG ELUTING STENTING TREATMENT PROCEDURE, A RASH OCCURRED. THE PATIENT HAD AN UNKNOWN SIZED TAXUS EXPRESS2 DRUG ELUTING STENT IMPLANTED TO TREAT AN UNSPECIFIED LESION. APPROXIMATELY TWO MONTHS FOLLOWING IMPLANT, THE PATIENT DEVELOPED A RASH. THE PATIENT'S INTERNIST HAD DISCONTINUED "ALL" OF THE PATIENT'S MEDICATIONS; HOWEVER, THIS DID NOT STOP THE RASH. THE PATIENT'S MEDICATIONS HAVE BEEN RESTARTED. THE PATIENT HAS CONSULTED WITH DERMATOLOGISTS WHO HAVE BEEN UNABLE TO SUCCESSFULLY TREAT THE PATIENT'S SYMPTOMS. ADDITIONAL INFORMATION WAS REQUESTED, BUT HAS NOT BEEN RECEIVED.

    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