BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1172201 · Received September 18, 2008

    Report

    Report Number
    2134265-2008-02727
    Event Type
    Malfunction
    Date Received
    September 18, 2008
    Date of Event
    August 26, 2008
    Report Date
    August 26, 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

    Additional Manufacturer Narrative · 1

    AS THE UNIT HAS NOT BEEN RETURNED, A TECHNICAL ANALYSIS IS UNABLE TO BE PERFORMED. A REVIEW OF THE MFG RECORDS FOUND THAT THE DEVICE MET MATERIAL, ASSEMBLY AND PRODUCT SPECS. THE MOST PROBABLE ROOT CAUSE OF THIS COMPLAINT IS OPERATIONAL CONTEXT, DUE TO THE LIKELIHOOD OF ANATOMICAL AND OR PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, STENT DAMAGE OCCURRED. THE 99% STENOSED LESION WAS LOCATED IN A CALCIFIED AND SEVERELY TORTUOUS RIGHT CORONARY ARTERY (RCA). THE LESION WAS PREDILATED AND A TAXUS EXPRESS2 3.0X24MM DRUG ELUTING STENT WAS ADVANCED TO THE LESION, BUT COULD NOT BE ADVANCED PAST THE MID RCA. SEVERAL ATTEMPTS WERE MADE WITH TWO DIFFERENT GUIDE WIRES AND THE LESION WAS PREDILATED AGAIN, HOWEVER, STENT PLACEMENT WAS STILL UNSUCCESSFUL. UPON REMOVAL OF THE DEVICE, IT WAS NOTED THAT THE EDGE OF THE STENT WAS LIFTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER TAXUS EXPRESS2 STENT. NO PT COMPLICATIONS OCCURRED. PT 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 3.0X24MM 11428289

    Patients

    Seq Age Sex Outcome Treatment
    1