BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1221537 · Received November 5, 2008

    Report

    Report Number
    2134265-2008-04226
    Event Type
    Malfunction
    Date Received
    November 5, 2008
    Date of Event
    October 16, 2008
    Report Date
    October 16, 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 NO DEVICE WAS RECEIVED FOR ANALYSIS, IT IS NOT POSSIBLE TO PERFORM ANY INSPECTIONS ON THE DEVICE. THEREFORE, IT IS NOT POSSIBLE TO DETERMINE IF ANY ISSUES EXISTED WITH THE ACTUAL UNIT THAT COULD HAVE CONTRIBUTED TO THE COMPLAINT. THERE WAS NO INDICATION OF A MANUFACTURING DEFECT OR ANOMALY IDENTIFIED WITHIN THE REVIEW OF THE MANUFACTURING RECORDS FOR THE REPORTED BATCH NUMBER. THE MANUFACTURING RECORDS HAVE BEEN REVIEWED AND NO ISSUES 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 DOCUMENTED AS OPERATIONAL CONTEXT DUE TO THE LIKELIHOOD THAT THE PATIENT ANATOMY OR OTHER PROCEDURAL FACTORS CONTRIBUTED TO THE REPORTED DIFFICULTY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, STENT DAMAGED OCCURRED. THE 90% STENOSED LESION WAS LOCATED IN A SEVERELY CALCIFIED AND SEVERELY TORTUOUS LEFT ANTERIOR DESCENDING ARTERY. THE PHYSICIAN ATTEMPTED TO DIRECT STENT WITH A TAUS EXPRESS2 3.0X20MM DRUG ELUTING STENT, BUT WAS UNABLE TO CROSS THE LESION DUE TO THE CALCIFICATION AND TORTUOUSITY. THE DEVICE WAS REMOVED FROM THE PATIENT, AND IT WAS NOTED THAT THE DISTAL EDGE OF THE STENT WAS LIFTED UP. THE PROCEDURE WAS COMPLETED WITH ANOTHER TAXUS EXPRESS2 STENT. NO PATIENT COMPLICATIONS OCCURRED. PATIENT 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 3.0X20MM 11108391

    Patients

    Seq Age Sex Outcome Treatment
    1 BMW GUIDE WIRE| 7FR MACH 1 GUIDE CATHETER