BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTÉ¿

    MDR report key: 2936028 · Received January 30, 2013

    Report

    Report Number
    2134265-2013-00273
    Event Type
    Malfunction
    Date Received
    January 30, 2013
    Date of Event
    November 14, 2012
    Report Date
    January 4, 2013
    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 MFR: THE RETURNED PRODUCT CONSISTED OF A LIBERTE-VERIFLEX STENT DELIVERY SYSTEM (SDS) AND STENT WITH NO OTHER DEVICES. THERE WAS CONTRAST IN THE INFLATION LUMEN. THE STENT HAD MOVED ON THE BALLOON 5MM DISTALLY FROM THE PROXIMAL MARKERBAND AND THERE WERE STENT STRUT IMPRESSIONS PRESENT ON THE SURFACE OF THE BALLOON BETWEEN THE MARKER BANDS, INDICATING THE STENT WAS APPROPRIATELY POSITIONED AND SECURED TO THE BALLOON IN MANUFACTURING. THE TIGHTLY FOLDED BALLOON INDICATED THE DEVICE WAS SUBJECTED TO NO POSITIVE (INFLATION) PRESSURE. THERE WERE MULTIPLE STENT STRUTS STRETCHED AND BENT IN VARIOUS LOCATIONS THROUGHOUT THE LENGTH OF THE STENT. THE MAGNIFIED INSPECTION PRESENTED NO DAMAGE OR IRREGULARITIES THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED CROSSING DIFFICULTY OR THE STENT DAMAGE AND STENT MOVED ON BALLOON. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE CLASSIFICATION OF THIS INVESTIGATION IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL PROCEDURAL FACTORS. (B)(4).

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, STENT DAMAGE WAS NOTED. THE 90% STENOSED TARGET LESION WAS LOCATED IN A SEVERELY TORTUOUS AND MODERATELY CALCIFIED RIGHT CORONARY ARTERY. THERE WAS A SIGNIFICANT LESION BEND GREATER THAN 90 DEGREES. THE 15 X 4.00 MM LIBERTE STENT DELIVERY SYSTEM WAS INTRODUCED BUT FAILED TO CROSS THE LESION BECAUSE A STENT STRUT WAS BENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTING THAT DURING A STENTING TREATMENT PROCEDURE, STENT DAMAGE WAS NOTED. THE 90% STENOSED TARGET LESION WAS LOCATED IN A SEVERELY TORTUOUS AND MODERATELY CALCIFIED RIGHT CORONARY ARTERY. THERE WAS A SIGNIFICANT LESION BEND GREATER THAN 90 DEGREES. THE 15 X 4.00 MM LIBERTE STENT DELIVERY SYSTEM WAS INTRODUCED BUT FAILED TO CROSS THE LESION BECAUSE A STENT STRUT WAS BENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40693 LIBERTÉ¿ STENT, CORONARY MAF BOSTON SCIENTIFIC - MAPLE GROVE H7493893816400 15082844

    Patients

    Seq Age Sex Outcome Treatment
    1