BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1003983 · Received February 25, 2008

    Report

    Report Number
    2134265-2008-00544
    Event Type
    Injury
    Date Received
    February 25, 2008
    Date of Event
    November 1, 2006
    Report Date
    February 1, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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 FOLLOWING A CORONARY ARTERY DRUG ELUTING STENTING PROCEDURE A RASH OCCURRED. THE PT HAD A 3.5X20MM TAXUS EXPRESS2 DRUG ELUTING STENT IMPLANTED TO TREAT AN UNSPECIFIED LESION. IT WAS REPORTED BY THE PT THAT "SHE HAS HAD A RASH SINCE THE STENT WAS INSERTED. THE RASH IS UNDER THE RIGHT BREAST AND ON THE ABDOMEN. THE RASH ITCHES INTERMITTENTLY. SHE HAS DISCONTINUED MOST OF HER MEDICATIONS AT THIS TIME AND THE RASH STILL PERSISTS." REPEATED REQUESTS FOR ADD'L INFO FROM THE PT'S PHYSICIANS HAVE BEEN MADE; HOWEVER, NO INFO HAS 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 3.5X20MM 8557242

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other