BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTE MONORAIL CORONARY STENT DELIVERY SYSTEM

    MDR report key: 1234070 · Received November 4, 2008

    Report

    Report Number
    2134265-2008-04201
    Event Type
    Malfunction
    Date Received
    November 4, 2008
    Date of Event
    September 30, 2008
    Report Date
    October 10, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    MAF
    PMA / PMN Number
    P040016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE UNPACKING FOR A CORONARY ARTERY STENTING TREATMENT PROCEDURE THE STENT FELL OFF THE BALLOON. THE 90% STENOSED, MILDLY CALCIFIED, TARGET LESION WAS IN THE MILDLY TORTUOUS PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 3.5X16MM LIBERTE BARE METAL STENT (BMS) HAD BEEN SELECTED TO TREAT THE TARGET LESION. WHILE UNPACKING THE DEVICE, IT WAS NOTICED THAT THE CATHETER WAS NOT DAMAGED; HOWEVER, THERE WAS NO STENT ON THE BALLOON. THE PHYSICIAN LOOKED FOR THE STENT, BUT THE STENT WAS NOT FOUND. THE DEVICE WAS NOT USED IN THE PROCEDURE AND DID NOT CONTACT THE PT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WAS NO PT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIBERTE MONORAIL CORONARY STENT DELIVERY SYSTEM STENT, CORONARY MAF BOSTON SCIENTIFIC NA 11410009

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR