BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1031992 · Received April 21, 2008

    Report

    Report Number
    2134265-2008-01145
    Event Type
    Malfunction
    Date Received
    April 21, 2008
    Date of Event
    March 24, 2008
    Report Date
    March 24, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    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

    DEVICE ANALYSIS. AS NO DEVICE WAS RECEIVED FOR ANALYSIS, IT IS NOT POSSIBLE TO PERFORM ANY INSPECTIONS ON THE DEVICE. THE MFG RECORDS FOR THIS BATCH HAVE BEEN REVIEWED AND NO ISSUE OR DISCREPANCIES WERE FOUND. THIS RECORDS REVIEW CONFIRMS THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY, AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE WILL BE CONSIDERED OPERATIONAL CONTEXT DUE TO ANATOMICAL AND OR PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE. A CAPA HAS BEEN OPENED TO ADDRESS THIS ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORONARY DRUG ELUTING STENTING PROCEDURE, STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE 90% STENOTIC SEVERELY TORTUOUS MID TO DISTAL RIGHT CORONARY ARTERY (RCA). THE PHYSICIAN ATTEMPTED TO CROSS THE LESION WITH THE 2.50X24MM TAXUS EXPRESS2 DRUG ELUTING STENT THREE TIMES, BUT ALL ATTEMPTS WERE UNSUCCESSFUL. THE DEVICE WAS REMOVED AND IT WAS NOTED THAT THE STENT EDGE WAS FLARED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND THE PATIENT CONDITION IS 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 CORPORATION 2.50X24MM 9665434

    Patients

    Seq Age Sex Outcome Treatment
    1