BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1220459 · Received November 4, 2008

    Report

    Report Number
    2134265-2008-04197
    Event Type
    Injury
    Date Received
    November 4, 2008
    Date of Event
    October 6, 2008
    Report Date
    October 8, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    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. 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 INFO FROM THE 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, A THROMBOSIS OCCURRED. THE PT PRESENTED WITH IN-STENT RESTENOSIS OF AN UNSPECIFIED STENT. A TAXUS EXPRESS2 3.0X20MM DRUG ELUTING STENT WAS IMPLANTED IN THE NON-TORTUOUS AND NON-CALCIFIED RIGHT CORONARY ARTERY. THE TAXUS EXPRESS2 STENT WAS POST DILATED WITH A QUANTUM MAVERICK BALLOON. THE PT WAS DISCHARGED AND 5 DAYS POST PROCEDURE, THE PT PRESENTED WITH SUBACUTE THROMBOSIS AND A MYOCARDIAL INFARCTION. THE THROMBUS WAS EXTRACTED WITH A THROMBECTOMY CATHETER AND A 3.0X8MM TAXUS EXPRESS2 WAS PLACED. THE PT DID EXPERIENCE A DECREASE IN VENTRICULAR FUNCTION. NO FURTHER PT COMPLICATIONS OCCURRED. PATIENT STATUS IS SATISFACTORY.

    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 3.0X20MM 11506637

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention