BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1161302 · Received September 15, 2008

    Report

    Report Number
    2134265-2008-02645
    Event Type
    Injury
    Date Received
    September 15, 2008
    Date of Event
    December 1, 2005
    Report Date
    August 18, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE ANALYSIS. AS NO DEVICE WAS RECEIVED FOR ANALYSIS IT IS NOT POSSIBLE TO PERFORM ANY INSPECTIONS ON THE DEVICE. AS THE BATCH NUMBER IS UNKNOWN A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE CARRIED OUT. THE ROOT CAUSE WILL BE DOCUMENTED AS ANTICIPATED PROCEDURAL COMPLICATION DUE TO A KNOW PHYSIOLOGICAL EFFECT OF THE PROCEDURE NOTED WITHIN THE DIRECTIONS FOR USE, AND/OR DEVICE LABELING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, STENT THROMBOSIS OCCURRED. THE PHYSICIAN IMPLANTED AN UNKNOWN SIZE TAXUS EXPRESS2 DRUG ELUTING STENT IN AN UNKNOWN ARTERY. FOUR MONTHS LATER, THE PATIENT EXPERIENCED IN-STENT THROMBOSIS. FURTHER INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN RECEIVED.

    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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other