BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTE' CORONARY STENT DELIVERY SYSTEM

    MDR report key: 2072144 · Received April 28, 2011

    Report

    Report Number
    2134265-2011-01820
    Event Type
    Malfunction
    Date Received
    April 28, 2011
    Date of Event
    February 28, 2011
    Report Date
    April 27, 2011
    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

    (B)(4): THE LIBERTE BARE STENT DELIVERY SYSTEM (SDS) WAS RECEIVED AND VISUAL EXAMINATION IDENTIFIED BLOOD AND CONTRAST IN THE WIRE LUMEN AND BALLOON. EXAMINATION IDENTIFIED PROXIMAL AND DISTAL STENT DAMAGE. A STRUT IN THE SECOND PROXIMAL ROW WAS FLARED AND 2 STRUTS AT THE DISTAL EDGE OF THE STENT WERE FLARED. NO FURTHER DAMAGE OR IRREGULARITIES WERE NOTED WITH 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)

    Description of Event or Problem · 1

    REPORTABLE BASED ON ANALYSIS COMPLETED ON (B)(6) 2011. IT WAS REPORTED THAT DURING A CORONARY STENTING TREATMENT PROCEDURE, DIFFICULTY CROSSING OCCURRED. THE PHYSICIAN ATTEMPTED TO ADVANCE THE 2.5MM X 20MM LIBERTE BARE CORONARY STENT DELIVERY SYSTEM (SDS) TO AN UNSPECIFIED LESION HOWEVER; THE SDS SYSTEM WOULD NOT CROSS THE LESION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE. HOWEVER, ANALYSIS OF THE 2.5MM X 20MM LIBERTE BARE CORONARY STENT DELIVERY SYSTEM REVEALED STENT DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIBERTE' CORONARY STENT DELIVERY SYSTEM STENT, CORONARY MAF BOSTON SCIENTIFIC - MAPLE GROVE H7493893820250 13034482

    Patients

    Seq Age Sex Outcome Treatment
    1