BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1003537 · Received February 26, 2008

    Report

    Report Number
    2134265-2008-00556
    Event Type
    Injury
    Date Received
    February 26, 2008
    Date of Event
    January 28, 2008
    Report Date
    January 28, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    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. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, STENT THROMBOSIS OCCURRED. THE PHYSICIAN SUCCESSFULLY IMPLANTED A 2.50X20MM TAXUS EXPRESS2 DRUG ELUTING STENT IN THE OBTUSE MARGINAL 2 (OM2). APPROXIMATELY THREE YEARS LATER, THE PATIENT PRESENTED WITH A MYOCARDIAL INFARCTION. THE PHYSICIAN USED IVUS AND FOUND THE VESSEL WAS A 3.5MM VESSEL. THE PHYSICIAN USED A 3.5MM QUANTUM BALLOON TO TREAT THE THROMBUS, AND "GOT A FINAL CROSS SECTION AREA OF 6.3." THE PATIENT HAD BEEN ON PLAVIX FOR OVER A YEAR, BUT THE PHYSICIAN DOES NOT KNOW WHEN THE PATIENT STOPPED TAKING PLAVIX. THE PATIENT CONDITION IS REPORTED AS OKAY. 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 2.50X20MM

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention