BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS¿ LIBERTÉ¿

    MDR report key: 2903578 · Received January 9, 2013

    Report

    Report Number
    2134265-2012-08156
    Event Type
    Malfunction
    Date Received
    January 9, 2013
    Date of Event
    September 25, 2012
    Report Date
    December 11, 2012
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. DEVICE IS COMBINATION PRODUCT. (B)(4). DEVICE EVALUATED BY MFR.: VISUAL EXAMINATION OF THE RETURNED DEVICE NOTED DISTAL STENT STRUT DAMAGE AND A NUMBER OF STRUTS WERE BENT BACK PROXIMALLY. THE BALLOON AND TIP SECTIONS OF THE DEVICE WERE VISUALLY AND MICROSCOPICALLY EXAMINED AND NO ISSUES WERE NOTED WITH THEIR PROFILES THAT COULD HAVE POTENTIALLY CONTRIBUTED TO THE COMPLAINT INCIDENT. THE BALLOON WAS TIGHTLY WRAPPED AND WAS NOT SUBJECTED TO POSITIVE PRESSURE. FURTHER EXAMINATION ALSO NOTED SLIGHT KINKING OF THE MID SHAFT REGION. NO FURTHER ISSUES WERE NOTED WITH THE RETURNED DEVICE WHICH COULD HAVE CONTRIBUTED TO THE REPORTED COMPLAINT. 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

    REPORTABLE BASED ON ANALYSIS COMPLETED ON (B)(4) 2012. IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE A STENT WAS UNABLE TO CROSS THE LESION. THE 2.5 X 16MM TAXUS LIBERTE STENT DELIVERY SYSTEM WAS ADVANCED MANY TIMES TO AN UNSPECIFIED LESION. DESPITE A GUIDE CATHETER EXCHANGE, AND THE BUDDY WIRE TECHNIQUE, THE DEVICE WAS UNABLE TO CROSS THE LESION. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE. HOWEVER, DEVICE ANALYSIS REVEALED STENT DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11311 TAXUS¿ LIBERTÉ¿ CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY H7493894016250 14764962

    Patients

    Seq Age Sex Outcome Treatment
    1