BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTE' MONORIAL CORONARY STENT DELIVERY SYSTEM

    MDR report key: 1133644 · Received August 20, 2008

    Report

    Report Number
    2134265-2008-02399
    Event Type
    Malfunction
    Date Received
    August 20, 2008
    Date of Event
    July 31, 2008
    Report Date
    July 31, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MAF
    PMA / PMN Number
    P040016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, SHAFT FRACTURE OCCURRED. THE PHYSICIAN WAS ATTEMPTING TO IMPLANT A 3.0X20MM LIBERTE' MONORAIL CORONARY STENT DELIVERY SYSTEM AT THE ANTERIOR DESCENDENT CORONARY ARTERY; HOWEVER, WHEN THE STENT DELIVERY SYSTEM WAS ADVANCED THE CATHETER SHAFT FRACTURED AT ITS PROXIMAL PART. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. PATIENT STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIBERTE' MONORIAL CORONARY STENT DELIVERY SYSTEM MAF STENT, CORONARY MAF BOSTON SCIENTIFIC CORPORATION NA 0011718274

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR