BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTE' MONORAIL CORONARY STENT DELIVERY SYSTEM

    MDR report key: 1030704 · Received April 15, 2008

    Report

    Report Number
    2134265-2008-01093
    Event Type
    Malfunction
    Date Received
    April 15, 2008
    Date of Event
    March 17, 2008
    Report Date
    March 18, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MAF
    PMA / PMN Number
    P0400016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE ANALYSIS: THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFO FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORONARY STENTING TREATMENT PROCEDURE, SHAFT FRACTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS DISTAL RIGHT CORONARY ARTERY (RCA). WHILE ATTEMPTING TO ACCESS THE RCA, THE SHAFT OF THE 3.00X12MM LIBERTE BARE METAL STENT BROKE IN THE PROXIMAL AREA OF THE FEMORAL ACCESS SITE. ALL OF THE PIECES WERE REMOVED FROM THE PT AND NO PT COMPLICATIONS WERE REPORTED. THE PHYSICIAN SUCCESSFULLY COMPLETED THE PROCEDURE WITH ANOTHER LIBERTE BARE METAL STENT OF THE SAME SIZE. THE PT INFO IS LISTED AS "WELL". NO FURTHER INFO WAS AVAIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIBERTE' MONORAIL CORONARY STENT DELIVERY SYSTEM MAF STENT, CORONARY MAF BOSTON SCIENTIFIC CORPORATION NA 0011435914

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR