BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL - ELUTING CORONARY STENT SYSTEM

    MDR report key: 1012971 · Received March 13, 2008

    Report

    Report Number
    2134265-2008-00759
    Event Type
    Injury
    Date Received
    March 13, 2008
    Date of Event
    July 6, 2007
    Report Date
    February 22, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    PATIENT

    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. IT IS NOTED THAT THIS DEVICE WAS IMPLANTED PAST THE BATCH EXPIRATION DATE.

    Description of Event or Problem · 1

    SAME CASE AS: 2134265-2008-00760. IT WAS REPORTED BY THE PATIENT THAT POST A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, ITCHING AND CHRONIC HIVES OCCURRED. THE PATIENT STARTED ITCHING IMMEDIATELY AFTER THE 2.75X24MM AND THE 3.00X12MM TAXUS EXPRESS2 DRUG ELUTING STENTS WERE IMPLANTED AND HAS BEEN DIAGNOSED WITH CHRONIC HIVES.

    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 2.75X24MM 8828090

    Patients

    Seq Age Sex Outcome Treatment
    1