BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1181129 · Received September 30, 2008

    Report

    Report Number
    2134265-2008-02847
    Event Type
    Injury
    Date Received
    September 30, 2008
    Report Date
    September 2, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO DEVICE WAS RECEIVED FOR ANALYSIS, IT IS NOT POSSIBLE TO PERFORM ANY INSPECTIONS ON THE DEVICE. THEREFORE, IT IS NOT POSSIBLE TO DETERMINE IF ANY ISSUES EXISTED WITH THE ACTUAL UNIT THAT COULD HAVE CONTRIBUTED TO THE COMPLAINT. IT IS NOTABLE THAT THERE IS NO EVIDENCE THAT INDICATES THE STENT INVOLVED IN THIS EVENT MALFUNCTIONED, OR IN SOME WAY DID NOT PERFORM TO SPECIFICATION THAT MAY HAVE RESULTED IN THIS EFFECT. THERE WAS NO INDICATION OF A MFG DEFECT OR ANOMALY IDENTIFIED WITHIN THE REVIEW OF THE MFG RECORDS FOR THE REPORTED BATCH NUMBER. THE MFG RECORDS HAVE VEEN REVIEWED AND NO ISSUES OR DISCREPANCIES WERE FOUND. THIS RECORDS REVIEW CONFIRMS THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY, AND PERFORMANCE SPECIFICATIONS. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, A THROMBOSIS OCCURRED. A TAXUS EXPRESS2 2.5X16MM DRUG ELUTING STENT WAS PLACED. POST PROCEDURE, THE PT PRESENTED WITH AN MI AND IN STENT THROMBOSIS. ADDITIONAL INFO 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 2.75X32MM 6880718

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other