BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1051068 · Received May 22, 2008

    Report

    Report Number
    2134265-2008-01470
    Event Type
    Injury
    Date Received
    May 22, 2008
    Date of Event
    April 29, 2008
    Report Date
    May 5, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WOULD 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 OF 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

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

    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 77 YR Other| R