BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIBERTÉ¿

    MDR report key: 2935847 · Received January 30, 2013

    Report

    Report Number
    2134265-2013-00180
    Event Type
    Injury
    Date Received
    January 30, 2013
    Date of Event
    November 19, 2012
    Report Date
    January 4, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    MAF
    PMA / PMN Number
    P040016
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: RETURNED PRODUCT CONSISTED OF A LIBERTE-VERIFLEX STENT DELIVERY SYSTEM WITHOUT THE STENT. THERE WAS BLOOD AND CONTRAST IN THE GUIDE WIRE LUMEN. THE BALLOON WAS IN A TIGHTLY FOLDED CONDITION INDICATING THERE WAS NO PRESSURE APPLIED. 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 MAGNIFIED INSPECTION PRESENTED NO DAMAGE OR IRREGULARITIES THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED CROSSING DIFFICULTY AND STENT DAMAGE OR THE STENT DETACHMENT. 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

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

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE STENT DELIVERY SYSTEM WAS ATTEMPTED TO BE WITHDRAWN THROUGH THE GUIDE CATHETER, THE STENT DISLODGED INSIDE OF THE PATIENT, THE STENT EMBOLIZED AND WAS RETRIEVED WITH A SNARE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE STENT DAMAGE OCCURRED. THE 20MM IN LENGTH AND 85% STENOSED TARGET LESION BEING TREATED WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED RIGHT CORONARY ARTERY (RCA). A 3.50X20MM LIBERTE STENT DELIVERY SYSTEM WAS ADVANCED TO THE RCA AND COULD NOT CROSS THE LESION AND A STRUT ON THE STENT BECAME BENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40637 LIBERTÉ¿ STENT, CORONARY MAF BOSTON SCIENTIFIC - MAPLE GROVE H7493893820350 15057952

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention