BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1161297 · Received September 15, 2008

    Report

    Report Number
    2134265-2008-02625
    Event Type
    Injury
    Date Received
    September 15, 2008
    Date of Event
    December 4, 2006
    Report Date
    August 18, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, 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. AS THE BATCH NUMBER IS UNKNOWN A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE CARRIED OUT. THE ROOT CAUSE IS DETERMINED TO BE 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 2134265-2008-02626. IT WAS REPORTED THAT POST A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, A LATE STENT THROMBOSIS OCCURRED. THE PHYSICIAN IMPLANTED A TAXUS EXPRESS2 DRUG ELUTING STENT, UNKNOWN SIZE, TO AN UNKNOWN VESSEL. NO PATIENT INJURIES OR COMPLICATIONS WERE REPORTED. THREE MONTHS POST PROCEDURE THE PATIENT PRESENTED WITH THROMBOSIS. ADDITIONAL INFORMATION 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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other