BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS¿ LIBERTÉ¿

    MDR report key: 2961169 · Received February 14, 2013

    Report

    Report Number
    2134265-2013-00698
    Event Type
    Malfunction
    Date Received
    February 14, 2013
    Date of Event
    January 20, 2013
    Report Date
    January 22, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER - THE HYPOTUBE SEPARATION WAS 58.5CM FROM THE EDGE OF THE STRAIN RELIEF. THE HYPOTUBE FRACTURE SURFACES WERE OVALED, WHICH SUGGESTS THE DEVICE WAS KINKED PRIOR TO SEPARATION. THE MIDSHAFT WAS KINKED ADJACENT TO THE GUIDEWIRE EXIT NOTCH. THERE WERE FLATTENED STENT STRUTS ON THE PROXIMAL END OF THE STENT. ALL MEASUREMENTS MET SPECIFICATION. THE DEVICE PRESENTED NO EVIDENCE OF ANY MATERIAL OR MANUFACTURING DEFICIENCIES THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT OR THE CONFIRMED DAMAGE TO THE DEVICE. 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).

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A BALLOON ANGIOPLASTY PROCEDURE, A SHAFT FRACTURE OCCURRED. THE 90% STENOSED CORONARY TARGET LESION WAS SEVERELY TORTUOUS AND SEVERELY CALCIFIED. AS THE 3.0X28MM TAXUS LIBERTE STENT WAS ADVANCED THE DEVICE WAS UNABLE TO CROSS THE LESION. UPON REMOVAL THE SHAFT BROKE. THE DISTAL SECTION OF THE DEVICE WAS REMOVED WITHOUT INCIDENT AND THE PROCEDURE WAS COMPLETED WITH A 3.0X20MM PROMUS ELEMENT STENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A BALLOON ANGIOPLASTY PROCEDURE, A SHAFT FRACTURE OCCURRED. THE 90% STENOSED CORONARY TARGET LESION WAS SEVERELY TORTUOUS AND SEVERELY CALCIFIED. AS THE 3.0X28MM TAXUS LIBERTE STENT WAS ADVANCED THE DEVICE WAS UNABLE TO CROSS THE LESION. UPON REMOVAL THE SHAFT BROKE. THE DISTAL SECTION OF THE DEVICE WAS REMOVED WITHOUT INCIDENT AND THE PROCEDURE WAS COMPLETED WITH A 3.0X20MM PROMUS ELEMENT STENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65665 TAXUS¿ LIBERTÉ¿ CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493894028300 15097423

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR