BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 2040257 · Received April 5, 2011

    Report

    Report Number
    2134265-2011-00920
    Event Type
    Malfunction
    Date Received
    April 5, 2011
    Date of Event
    March 10, 2011
    Report Date
    March 10, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS COMBINATION PRODUCT. DEVICE EVALUATED BY MANUFACTURER: THE COMPLAINT DEVICE WAS NOT RECEIVED FOR ANALYSIS. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL/PROCEDURAL FACTORS. (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE WITHDRAWAL RESISTANCE AND STENT DAMAGE OCCURRED. THE MID RIGHT CORONARY ARTERY (RCA) WAS PREDILATED WITH AN APEX BALLOON AND THEN A 4.00X32MM TAXUS LIBERTE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE LESION; HOWEVER, THE DEVICE WAS UNABLE TO CROSS THE PREVIOUSLY PLACED STENT IN THE LESION. DURING REMOVAL OF THE SDS IT WAS NOTED THAT THE DEVICE WAS STUCK ON THE PREVIOUSLY PLACED STENT AND THE PHYSICIAN EXPERIENCED WITHDRAWAL RESISTANCE. THE DEVICE WAS REMOVED FROM THE PATIENT NORMALLY AND IT WAS NOTED THAT THE PREVIOUSLY PLACED STENT STAYED WELL POSITIONED AND APPOSED IN THE LESION. ONCE THE DEVICE WAS OUTSIDE THE PATIENT IT WAS NOTED THAT THE DISTAL END OF THE STENT WAS DAMAGED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DIFFERENT DEVICE WITH NO PATIENT COMPLICATIONS REPORTED. THE PATIENT'S CURRENT CONDITION IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493893632400

    Patients

    Seq Age Sex Outcome Treatment
    1 APEX BALLOON CATHETER