BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1083448 · Received July 29, 2008

    Report

    Report Number
    2134265-2008-02115
    Event Type
    Injury
    Date Received
    July 29, 2008
    Report Date
    July 3, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO DEVICE WAS RECEIVED FOR ANALYSIS, IT IS NOT POSSIBLE TO PERFORM ANY INSPECTIONS ON THE DEVICE. AS THE BATCH NUMBER IS UNK, A REVIEW OF THE MFG RECORDS COULD NOT BE CARRIED OUT. THE ROOT CAUSE WILL BE DOCUMENTED AS ANTICIPATED PROCEDURAL COMPLICATION, DUE TO A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE NOTED WITHIN THE DIRECTIONS FOR USE, AND/OR DEVICE LABELING.

    Description of Event or Problem · 1

    IT WAS REPORTED 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. POST STENT IMPLANTATION THE PT EXPERIENCED PERSISTENT WEIGHT LOSS, DIARRHEA AND SKIN RASHES. THE PT HAS HAD A GRADUAL ELIMINATION OF MEDICATIONS TO DEFINE HYPERSENSITIVITY TO POSSIBLE STENT COMPONENTS OR MEDICATIONS. ADD'L INFO REGARDING THIS EVENT HAS BEEN REQUESTED.

    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