BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1033525 · Received April 24, 2008

    Report

    Report Number
    2134265-2008-01188
    Event Type
    Malfunction
    Date Received
    April 24, 2008
    Date of Event
    April 8, 2008
    Report Date
    April 8, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 DURING A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, STENT DAMAGE OCCURRED. THE 90% STENOSED LESION BEING TREATED WAS LOCATED IN THE CALCIFIED, SEVERELY TORTUOUS PROXIMAL LEFT CIRCUMFLEX (LCX) ARTERY. THE PHYSICIAN ATTEMPTED TO PLACE THE 2.75X8MM TAXUS EXPRESS2 DRUG ELUTING STENT, BUT WAS UNABLE TO CROSS THE LESION. IT WAS NOTED THAT THE STENT EDGE WAS LIFTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER TAXUS STENT. NO PT COMPLICATIONS WERE REPORTED. PT STATUS REPORTED AS "GOOD".

    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 2.75X8 MM 11161950

    Patients

    Seq Age Sex Outcome Treatment
    1