BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1190297 · Received October 6, 2008

    Report

    Report Number
    2134265-2008-02915
    Event Type
    Injury
    Date Received
    October 6, 2008
    Date of Event
    September 13, 2008
    Report Date
    September 9, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS THE UNIT HAS NOT BEEN RETURNED, A TECHNICAL ANALYSIS COULD NOT BE PERFORMED. THE BATCH NUMBER OF THIS COMPLAINT IS UNK. A SHIP HISTORY PERFORMED IDENTIFIED NO POTENTIAL BATCHES SOLD TO THIS CUSTOMER. THE MOST PROBABLE ROOT CAUSE CLASSIFICATION IS 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 TEN DAYS AFTER THE PHYSICIAN PLACED A 3.00X20MM TAXUS EXPRESS2 DRUG ELUTING STENT, A THROMBOSIS OCCURRED. THE 100% STENOSED LESION BEING TREATED WAS LOCATED IN THE NON-CALCIFIED MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. PT STATUS REPORTED AS "STABLE". ADDITIONAL INFO WAS REQUESTED, BUT NOT PROVIDED.

    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 3.00X20MM

    Patients

    Seq Age Sex Outcome Treatment
    1 Other