BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTE' MONORAIL CORONARY STENT DELIVERY SYSTEM

    MDR report key: 1000574 · Received February 15, 2008

    Report

    Report Number
    2134265-2008-00442
    Event Type
    Malfunction
    Date Received
    February 15, 2008
    Date of Event
    January 18, 2008
    Report Date
    January 18, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    MAF
    PMA / PMN Number
    P040016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORONARY STENTING TREATMENT PROCEDURE, A SHAFT FRACTURE OCCURRED. THE LESION WAS LOCATED IN THE PROXIMAL AND DISTAL LEFT ANTERIOR DESCENDING ARTERY. A 2.75X24MM LIBERTE STENT WAS INITIALLY IMPLANTED. THE PHYSICIAN THEN DECIDED TO PLACE A 3.0X20MM LIBERTE STENT AT THE PROXIMAL PORTION. THE DELIVERY DEVICE WAS ADVANCED THROUGH THE GUIDE CATHETER AND WHEN THE PHYSICIAN BEGAN TO DEPLOY THE DEVICE, THE SHAFT BROKE, OUTSIDE THE PT, AT THE PROXIMAL PORTION OF THE SHAFT. THE STENT DELIVERY SYS WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER 3.0X20MM LIBERTE' STENT. NO PT COMPLICATIONS OCCURRED. PT STATUS IS SATISFACTORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIBERTE' MONORAIL CORONARY STENT DELIVERY SYSTEM MAF STENT, CORONARY MAF BOSTON SCIENTIFIC NA 9212625

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR