BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTÉ¿

    MDR report key: 2904801 · Received January 9, 2013

    Report

    Report Number
    2134265-2012-08192
    Event Type
    Malfunction
    Date Received
    January 9, 2013
    Date of Event
    September 8, 2012
    Report Date
    December 11, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    MAF
    PMA / PMN Number
    P040016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER - RETURNED PRODUCT CONSISTED OF A LIBERTE-VERIFLEX STENT DELIVERY SYSTEM (SDS) AND STENT WITH THE STENT PROTECTOR AND PRODUCT MANDREL PARTIALLY LOADED. THERE WAS CONTRAST IN THE INFLATION LUMEN. THE PRESENCE OF CONTRAST IN THE INFLATION LUMEN, AND THE POSITION OF THE STENT PROTECTOR AND PRODUCT MANDREL SUGGEST THE STENT PROTECTOR AND PRODUCT MANDREL WERE REPLACED AFTER THE REPORTED FAILED ATTEMPT TO CROSS THE TARGET LESION. THE STENT WAS CENTERED BETWEEN THE MARKERBANDS ON THE TIGHTLY FOLDED BALLOON; THERE WAS NO INDICATION THE DEVICE WAS SUBJECTED TO POSITIVE (INFLATION) PRESSURE. THERE WERE MULTIPLE STENT STRUTS STRETCHED AND BENT IN THE FIRST TWO PROXIMAL ROWS. THERE WAS DISTAL TIP DAMAGE. THE MAGNIFIED INSPECTION PRESENTED NO DAMAGE OR IRREGULARITIES THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED CROSSING DIFFICULTY OR THE STENT AND TIP DAMAGE. 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 (B)(6) 2012. IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY, THE DEVICE WAS UNABLE TO CROSS THE LESION. THE SEQUENTIAL NARROWINGS OF THE RIGHT CORONARY ARTERY (RCA) WERE 95%, 55% AND 99% STENOSED. A 3.0X12MM LIBERTE BARE METAL STENT (BMS), A 3.5X20 NON-BSC STENT, AND A 3.5X28MM NON-BSC STENTS WERE IMPLANTED. TO TREAT A DISTAL DISSECTION REGION IN THE "LCA CROX CDU" A 3.0X16MM LIBERTE BMS WAS ADVANCED; HOWEVER, WAS UNABLE TO CROSS. A 3.5X16MM LIBERTE BMS WAS ALSO ADVANCED AND ALSO COULD NOT CROSS. NO FURTHER INTERVENTION WAS PERFORMED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE. HOWEVER; RETURNED DEVICE ANALYSIS REVEALED STENT DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11631 LIBERTÉ¿ STENT, CORONARY MAF BOSTON SCIENTIFIC - MAPLE GROVE H7493893816350 15305505

    Patients

    Seq Age Sex Outcome Treatment
    1