BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERIFLEX (LIBERTE) CORONARY STENT DELIVERY SYSTEM

    MDR report key: 1905088 · Received November 22, 2010

    Report

    Report Number
    2134265-2010-05132
    Event Type
    Malfunction
    Date Received
    November 22, 2010
    Date of Event
    September 21, 2010
    Report Date
    November 4, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    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: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. THE BATCH NUMBER IS UNKNOWN; THEREFORE THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE CAN NOT BE REVIEWED. IF ANY FURTHER RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE STENT DAMAGE OCCURRED. THE 90% STENOTIC LESION WAS LOCATED IN THE MODERATELY TORTUOUS PROXIMAL LEFT ANTERIOR DESCENDING ARTERY. THE PHYSICIAN ADVANCED THE 4.0X12MM VERIFLEX STENT TO THE LESION, BUT WAS UNABLE TO CROSS. WHEN THE DEVICE WAS REMOVED IT WAS NOTED THAT THE STENT STRUT WAS DAMAGED. THE PROCEDURE WAS COMPLETED WITH AN UNSPECIFIED DEVICE. NO COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERIFLEX (LIBERTE) CORONARY STENT DELIVERY SYSTEM STENT, CORONARY MAF BOSTON SCIENTIFIC - GALWAY H7493893412400

    Patients

    Seq Age Sex Outcome Treatment
    1 LAUNCHER GUIDE CATHETER