BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1162102 · Received September 16, 2008

    Report

    Report Number
    2134265-2008-02655
    Event Type
    Injury
    Date Received
    September 16, 2008
    Report Date
    August 22, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    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 MFG RECORDS HAVE BEEN 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, AND/OR DEVICE LABELING.

    Description of Event or Problem · 1

    SAME CASE AS 2134265-2008-02656. IT WAS REPORTED THAT POST A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, A LATE STENT THROMBOSIS AND MYOCARDIAL INFARCTION OCCURRED. THE PHYSICIAN PLACED TWO TAXUS EXPRESS2 DRUG ELUTING STENTS, A 2.5X24MM AND A 2.75X28MM TO AN UNK VESSEL. POST IMPLANTATION A THROMBOSIS AND A MYOCARDIAL INFARCTION OCCURRED. ADDITIONAL 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 CORPORATION 2.5X24MM 8673293

    Patients

    Seq Age Sex Outcome Treatment
    1 Other