BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1172140 · Received September 18, 2008

    Report

    Report Number
    2134265-2008-02714
    Event Type
    Malfunction
    Date Received
    September 18, 2008
    Date of Event
    August 26, 2008
    Report Date
    August 27, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, SLOW DEFLATION OF THE STENT DELIVERY BALLOON OCCURRED. THE PHYSICIAN IMPLANTED A TAXUS EXPRESS2 2.75X28MM DRUG ELUTING STENT TO AN UNKNOWN VESSEL. THE STENT WAS DEPLOYED AT 14 ATMS. THE PHYSICIAN ATTEMPTED TO DEFLATE THE STENT DELIVERY BALLOON, BUT IT WOULD NOT DEFLATE. THE BALLOON WAS LEFT IN AND FINALLY DEFLATED AFTER 50 SECONDS. NO PATIENT INJURIES OR COMPLICATIONS WERE REPORTED. PATIENT STATUS POST PROCEDURE IS NOTED GOOD. 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 2.75X28MM 11306218

    Patients

    Seq Age Sex Outcome Treatment
    1