BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 2103511 · Received May 26, 2011

    Report

    Report Number
    2134265-2011-01896
    Event Type
    Malfunction
    Date Received
    May 26, 2011
    Report Date
    April 29, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MANUFACTURER: EXAMINATION OF THE RETURNED DEVICE REVEALED THAT THE STENT DELIVERY SYSTEM (SDS) WAS RECEIVED ON A GUIDEWIRE, PARTIALLY LOADED INTO A NON BSC ACCESSORY DEVICE. THERE WAS DRIED CONTRAST ALONG THE ENTIRE LENGTH OF THE OUTER SHAFT. THE BALLOON WAS TIGHTLY FOLDED WITH THE STENT PARTIALLY STRIPPED FROM THE BALLOON INSIDE THE ACCESSORY DEVICE. ATTEMPTS TO FREE THE DEVICE WERE UNSUCCESSFUL. THE ACCESSORY DEVICE WAS ABLE TO BE LOOSENED ENOUGH SO THE SDS WAS ABLE TO BE ADVANCED DISTALLY TO EXAMINE THE STENT. THE STENT WAS COVERED WITH DRIED BLOOD AND BUNCHED AT THE PROXIMAL END. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS CONSIDERED HANDLING DAMAGE AS THE EVENT OCCURRED PRIOR TO PATIENT CONTACT. (B)(4).

    Description of Event or Problem · 1

    REPORTABLE BASED ON ANALYSIS COMPLETED ON (B)(6) 2011. IT WAS REPORTED THAT DURING PREPARATION FOR A STENTING TREATMENT PROCEDURE, INSERTION DIFFICULTIES OCCURRED. THE 38X2.75MM TAXUS LIBERTE LONG STENT DELIVERY SYSTEM (SDS) WAS ADVANCED THROUGH THE NON-BSC TOUGHY DEVICE AND GOT STUCK. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS OK. HOWEVER, DEVICE ANALYSIS REVEALED THE STENT WAS DAMAGED AND HAD MOVED ON THE BALLOON.

    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 H7493893638270 13733772

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR COPILOT