BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1234051 · Received November 4, 2008

    Report

    Report Number
    2134265-2008-04205
    Event Type
    Malfunction
    Date Received
    November 4, 2008
    Date of Event
    October 8, 2008
    Report Date
    October 8, 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

    THE SDS WITH STENT WAS VISUALLY AND TACTILELY INSPECTED INCLUDING MICROSCOPIC EXAMINATION OF THE ENTIRE LENGTH OF THE DEVICE. THE MIDSHAFT, INCLUDING THE COREWIRE, INCLUDED A KINK APPROXIMATELY 1.9 CM FROM THE WIRE PORT. EXAMINATION OF THE COREWIRE AND SHAFT MATERIAL AT AND ADJACENT TO THE KINK PRESENTED NO EVIDENCE OF MATERIAL OR MANUFACTURING DEFICIENCIES THAT COULD HAVE CONTRIBUTED TO THE KINK. IT WAS ALSO NOTED THAT SEVERAL LOCATIONS OF THE OUTER SHAFT WERE STICKY TO THE TOUCH. MICROSCOPIC EXAMINATION OF THESE AREAS PRESENTED A SOFT, CLEAR, GUMMY MATERIAL BELIEVED TO BE PARTIALLY DRIED CONTRAST MEDIA OR BIO-MATERIAL. EXAMINATION OF THE DISTAL END OF THE DEVICE REVEALED STENT DAMAGE CONSISTING OF 2 FLARED DISTAL STRUTS. THERE WERE NO OTHER ANOMALIES IN THE DISTAL TIP OR DISTAL OUTER SHAFT AND THERE WAS NO EVIDENCE OF MATERIAL OR MANUFACTURING DEFICIENCIES THAT COULD HAVE CONTRIBUTED TO THE FLARED STRUTS. FUNCTIONAL TESTING OF THE RETURNED DEVICE AND MEASURED OF THE LUMEN DIAMETER WERE NOT POSSIBLE DUE TO THE RETURNED CONDITION OF THE DEVICE. 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 OF THIS COMPLAINT CAN BE ATTRIBUTED TO OPERATIONAL CONTEXT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE THE CATHETER FROZE ON THE GUIDE WIRE. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS DISTAL LEFT CIRCUMFLEX (LCX). THE LESION WAS PREDILATED WITH A 2.50X20MM NON BSC BALLOON AFTER IVUS WAS PERFORMED. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE THE 2.50X20MM TAXUS EXPRESS2 DRUG ELUTING STENT (DES) TO THE LESION; HOWEVER, THE STENT DELIVERY SYSTEM (SDS) FROZE ON THE NON BSC GUIDE WIRE DURING ADVANCEMENT. THE TAXUS EXPRESS2 DES WAS UNABLE TO MOVE AND THE SDS AND GUIDE WIRE WERE SUCCESSFULLY REMOVED AS A SYSTEM FROM THE PT. ANOTHER NON BSC GUIDE WIRE CROSSED THE LESION AND ANOTHER 2.50X20MM TAXUS EXPRESS2 DES WAS IMPLANTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO PT COMPLICATIONS REPORTED. THE PT'S CURRENT CONDITION IS 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 2.50X20MM 11055513

    Patients

    Seq Age Sex Outcome Treatment
    1 AVITA 2.5X20MM BALLOON| PILOT 50 GUIDE WIRE| BALANCE GUIDE WIRE