BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1172065 · Received September 23, 2008

    Report

    Report Number
    2134265-2008-02765
    Event Type
    Injury
    Date Received
    September 23, 2008
    Report Date
    September 1, 2008
    Manufacturer
    BOSTON SCIENTIC
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. THE BATCH NUMBER OF THIS COMPLAINT IS UNK. A SHIP HISTORY PERFORMED IDENTIFIED NO POTENTIAL BATCHES SOLD TO THIS CUSTOMER. THE ROOT CAUSE IS DETERMINED TO BE ANTICIPATED PROCEDURAL COMPLICATION AS THE DEVICE RELATED ROOT CAUSE DOES NOT APPLY AND THE COMPLAINT IS DUE TO A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE NOTED WITHIN THE DFU, AND/OR DEVICE LABELING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, HAIR LOSS OCCURRED. THE PHYSICIAN IMPLANTED A TAXUS EXPRESS2 2.5X20MM DRUG ELUTING STENT TO THE RIGHT CORONARY ARTERY (RCA). A FEW MONTHS POST STENT IMPLANTATION THE PT EXPERIENCED HAIR LOSS. ADDITIONAL INFO REGARDING THIS EVENT IS NOT 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 SCIENTIC 2.5X20MM

    Patients

    Seq Age Sex Outcome Treatment
    1 Other