BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIBERTE MONORAIL CORONARY STENT DELIVERY SYSTEM

    MDR report key: 1220465 · Received November 4, 2008

    Report

    Report Number
    2134265-2008-04200
    Event Type
    Injury
    Date Received
    November 4, 2008
    Date of Event
    September 30, 2008
    Report Date
    October 7, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    MAF
    PMA / PMN Number
    P040016
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS THE UNIT HAS NOT BEEN RETURNED, A TECHNICAL ANALYSIS WAS UNABLE TO BE PERFORMED. A REVIEW OF THE MANUFACTURING RECORDS FOUND THAT THE DEVICE MET MATERIAL, ASSEMBLY AND PRODUCT SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE OF THIS COMPLAINT IS OPERATIONAL CONTEXT DUE TO THE LIKELIHOOD OF ANATOMICAL AND OR PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORONARY STENTING TREATMENT PROCEDURE, REMOVAL DIFFICULTY OCCURRED. THE 80% STENOSIS LESION WAS LOCATED IN A MODERATELY TORTUOUS AND NON CALCIFIED MID LEFT ANTERIOR DESCENDING ARTERY. THE LESION WAS PREDILATED AND A 3.5X12MM LIBERTE STENT WAS PLACED. A 2.5X8MM LIBERTE BARE METAL STENT WAS THEN INSERTED BUT WAS UNABLE TO CROSS THE LESION. WHEN THE PHYSICIAN ATTEMPTED TO REMOVE THE DEVICE, RESISTANCE WAS ENCOUNTERED. THE PHYSICIAN THEN OPTED TO DEPLOY THE STENT, WHICH WAS IMPLANTED SUPERIOR TO THE LESION. NO FURTHER INTERVENTION WAS PERFORMED. NO PATIENT COMPLICATIONS OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIBERTE MONORAIL CORONARY STENT DELIVERY SYSTEM MAF STENT, CORONARY MAF BOSTON SCIENTIFIC N/A 0008617659

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other