BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1171185 · Received September 22, 2008

    Report

    Report Number
    2134265-2008-02687
    Event Type
    Injury
    Date Received
    September 22, 2008
    Report Date
    September 2, 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

    DEVICE ANALYSIS. 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 MANUFACTURING RECORDS FOR THIS BATCH 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 MFR#2134265-2008-02688. IT WAS REPORTED THAT POST A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, STENT THROMBOSIS AND/OR MYOCARDIAL INFARCTION OCCURRED. THE PHYSICIAN IMPLANTED A 2.75X24MM TAXUS EXPRESS2 DRUG ELUTING STENT AND A 2.50X20MM TAXUS EXPRESS2 DRUG ELUTING STENT IN AN UNSPECIFIED LOCATION. AN UNKNOWN AMOUNT OF TIME LATER, THE PATIENT SUFFERED A STENT THROMBOSIS AND/OR A MYOCARDIAL INFARCTION. FURTHER INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN 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 CORPORATION 2.75X24MM 6997365

    Patients

    Seq Age Sex Outcome Treatment
    1 Other