BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTE' CORONARY STENT DELIVERY SYSTEM

    MDR report key: 1897039 · Received November 11, 2010

    Report

    Report Number
    2134265-2010-04846
    Event Type
    Malfunction
    Date Received
    November 11, 2010
    Date of Event
    October 15, 2010
    Report Date
    October 16, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    MAF
    PMA / PMN Number
    P040016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER - THE DEVICE WAS RECEIVED IN TWO SECTIONS AS A RESULT OF A BREAK IN THE HYPOTUBE. THE BREAK WAS LOCATED DISTAL TO THE STRAIN RELIEF. AN EXAMINATION OF THE BREAK SITE FOUND THAT THE BREAK OCCURRED AS A RESULT OF A SEVERE KINK THAT DEVELOPED IN THE HYPOTUBE. THE CRIMPED STENT, BALLOON AND TIP SECTIONS OF THE DEVICE WERE VISUALLY EXAMINED AND NO ISSUES WERE NOTED. 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

    IT WAS REPORTED THAT DURING A CORONARY STENTING TREATMENT PROCEDURE, A SHAFT BREAK OCCURRED. THE TARGET LESION BEING TREATED WAS LOCATED IN THE SEVERELY TORTUOUS LEFT CIRCUMFLEX ARTERY (LCX). DURING THE PROCEDURE, IT WAS NOTED THAT THE 3.00X16MM LIBERTE' STENT DELIVERY SYSTEM WAS ADVANCED TO THE LESION BUT DID NOT PASS SMOOTHLY THROUGH THE VESSEL AND THEN THE PHYSICIAN NOTICED THAT THE SHAFT BROKE. THE PHYSICIAN USED ANOTHER 3.00X12MM STENT TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORONARY STENTING TREATMENT PROCEDURE, A SHAFT BREAK OCCURRED. THE TARGET LESION BEING TREATED WAS LOCATED IN THE SEVERELY TORTUOUS LEFT CIRCUMFLEX ARTERY (LCX). DURING THE PROCEDURE, IT WAS NOTED THAT THE 3.00X16MM LIBERTE' STENT DELIVERY SYSTEM WAS ADVANCED TO THE LESION BUT DID NOT PASS SMOOTHLY THROUGH THE VESSEL AND THEN THE PHYSICIAN NOTICED THAT THE SHAFT BROKE. THE PHYSICIAN USED ANOTHER 3.00X12MM STENT TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIBERTE' CORONARY STENT DELIVERY SYSTEM STENT, CORONARY MAF BOSTON SCIENTIFIC - GALWAY H7493893816300 0013346480

    Patients

    Seq Age Sex Outcome Treatment
    1