BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1212641 · Received October 24, 2008

    Report

    Report Number
    2134265-2008-03500
    Event Type
    Injury
    Date Received
    October 24, 2008
    Date of Event
    September 25, 2008
    Report Date
    September 30, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVAL; 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 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, A THROMBOSIS OCCURRED. THE PHYSICIAN IMPLANTED A TAXUS EXPRESS2 2.5X12MM DRUG ELUTING STENT TO THE CIRCUMFLEX (CX) ARTERY. THIS PROCEDURE WAS PERFORMED AT A DIFFERENT FACILITY. NO PT INJURIES OR COMPLICATIONS WERE REPORTED. THREE DAYS POST STENT IMPLANTATION THE PT PRESENTED TO THIS FACILITY AND ANGIOGRAPHY CONFIRMED A THROMBOSIS IN THE PREVIOUSLY PLACED TAXUS STENT. A PRONTO ASPIRATION CATHETER WAS USED ALONG WITH IVUS. A TAXUS EXPRESS2 2.5X12MM WAS PLACED, BUT THE PHYSICIAN FELT IT WAS UNDERDEPLOYED SO PERFORMED POST DILATATION WITH A QUANTUM MAVERICK 3.0X12MM BALLOON. A TAXUS EXPRESS2 3.0X16MM DRUG ELUTING STENT WAS THEN DEPLOYED PROXIMAL TO THE 3.0X12MM STENT. NO ADDITIONAL PT INJURIES OR COMPLICATIONS WERE REPORTED. PT STATUS POST PROCEDURE IS NOTED AS FINE. ADDITIONAL INFO 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 2.5X12MM

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention EBU4 GUIDE CATHETER