BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1052101 · Received May 21, 2008

    Report

    Report Number
    2134265-2008-01463
    Event Type
    Malfunction
    Date Received
    May 21, 2008
    Date of Event
    May 2, 2008
    Report Date
    May 2, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS THE UNIT HAS NOT BEEN RETURNED, A TECHNICAL ANALYSIS COULD NOT BE PERFORMED. A LABELING REVIEW IDENTIFIED THAT THE DEVICE WAS USED AS PER THE TAXUS EXPRESS2 DIRECTIONS FOR USE. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THIS PARTICULAR BATCH FOUND THAT THE DEVICE MET ITS MATERIAL, ASSEMBLY AND PRODUCT SPECIFICATIONS AT THE TIME OF RELEASE TO DISTRIBUTION. BASED ON THIS ANALYSIS, THE MOST PROBABLE ROOT CAUSE OF THIS COMPLAINT CAN BE ATTRIBUTED TO OPERATIONAL CONTEXT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORONARY ARTERY DRUG ELUTING STENTING TREATMENT PROCEDURE STENT DAMAGE OCCURRED. THE 75% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS MID RIGHT CORONARY ARTERY (RCA). THE LESION WAS PREDILATED WITH A NON BSC DEVICE, BUT THE PHYSICIAN WAS UNABLE TO CROSS THE LESION WITH THE 3.50X20MM TAXUS EXPRESS2 DRUG ELUTING STENT (DES). WHEN EXCHANGING THE GUIDE WIRE, THE STENT DELIVERY SYSTEM (SDS) WAS REMOVED AND IT WAS NOTED THAT THE PROXIMAL EDGE OF THE STENT WAS FLARED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED WITH THE PATIENT'S CURRENT CONDITION LISTED 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 3.50X20MM 11361744

    Patients

    Seq Age Sex Outcome Treatment
    1