BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS EXPRESS2 PACLITAXEL -ELUTING CORONARY STE

    MDR report key: 5369596 · Received January 6, 2006

    Report

    Report Number
    6000089-2006-02664
    Event Type
    Malfunction
    Date Received
    January 6, 2006
    Date of Event
    December 6, 2005
    Report Date
    January 4, 2006
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    NIQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    1

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS AS OF THE DATE OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    THE STENT REMAINS IN THE PT AND THE DELIVERY DEVICE WAS NOT RETURNED, THEREFORE NO DIRECT PRODUCT ANALYSIS WILL BE AVAILABLE. THE SHOPFLOOR PAPERWORK FOR THIS BATCH WAS REVIEWED. ALL MANUFACTURING AND QUALITY ASSURANCE TESTING WAS CARRIED OUT IN ACCORDANCE WITH STANDARD PROCEDURES. THE SHOPFLOOR PAPERWORK FOR THIS BATCH SHOWS THAT THE PRODUCT MET ITS SPECIFICATIONS. AS NO DEVICE WAS RECEIVED FOR ANALYSIS, IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF THE DIFFICULTIES EXPERIENCED WITH THIS COMPLAINT INCIDENT.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED IN TWO SECTIONS AS A RESULT OF A BREAK IN THE MIDSHAFT EXTRUSION. THE BREAK WAS LOCATED APPROXIMATELY 14.6 CM DISTAL FROM ITS PROXIMAL EDGE. THE MIDSHAFT EXHIBITED CLEAR SIGNS OF STRETCHING. AN EXAMINATION OF THE BALLOON FOUND THAT THE BALLOON HAD A LARGE BUILD UP OF SOLIDIFIED BLOOD. IT WAS NOTED THAT THE BALLOON APPEARED TO BE BUNCHED TOWARDS THE DISTAL END OF THE BALLOON. THE PROXIMAL WELD AREA WAS MEASURED AT 0.3034 INCH. IT APPEARS THAT THE BALLOON WAS NOT FULLY DEFLATED DURING WITHDRAWAL. THE SHIP FLOOR PAPERWORK WAS REVIEWED FOR THIS PARTICULAR BATCH OF DEVICES (8043495 & 7950039)_ AND NO ANOMALIES WERE NOTED FROM THIS REVIEW THAT COULD CORRELATE TO THE DIFFICULTIES THAT WAS EXPERIENCED BY THE PHYSICIAN DURING THE USE OF THIS PRODUCT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORONARY ARTERY DRUG ELUTING STENTING TREATMENT PROCEDURE, A COMPLETE SHAFT FRACTURE OCCURRED. THE LESION BEING TREATED WAS LOCATED IN THE OBTUSE MARGINAL (OM). THE PHYSICIAN SUCCESSFULLY DEPLOYED A TAXUS EXPRESS2 3.5 X 12 MM DRUG ELUTING STING. HOWEVER, AS THE PHYSICIAN RETRACTED THE STENT DELIVERY SYSTEM (SDS) INTO THE GUIDE CATHETER A COMPLETE SHAFT FRACTURE OCCURRED. THE FRACTURED CATHETER WAS REMOVED FROM THE PATIENT'S BODY. NO PATIENT COMPLICATIONS OR INJURIES WERE REPORTED. PATIENT STATUS IS REPORTED AS "FINE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS EXPRESS2 PACLITAXEL -ELUTING CORONARY STE DRUG COATED STENT NIQ BOSTON SCIENTIFIC CORP. 3.50X12MM 8043495

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR