BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIBERTE MONORAIL CORONARY STENT DEL SYS

    MDR report key: 774686 · Received October 27, 2006

    Report

    Report Number
    6000089-2006-02337
    Event Type
    Injury
    Date Received
    October 27, 2006
    Date of Event
    September 29, 2006
    Report Date
    September 29, 2006
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    MAF
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE STENT REMAINS IN THE PATIENT AND THE COMPLAINANT INDICATED THAT THE DELIVERY DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE, AND WE ARE NOT ABLE TO DETERMINE THE ROOT CAUSE OF THIS EVENT. SHOULD FURTHER RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE FILED. A REVIEW OF THE MANUFACTURING RECORDS FOR BATCH 8911393 SHOWS THAT THE DEVICE MET ITS MATERIAL, ASSEMBLY AND PRODUCT SPECIFICATIONS AT THE TIME OF ITS RELEASE TO DISTRIBUTION. THIS BATCH NUMBER HAS NO ASSOCIATED COMPLAINTS TO DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PCI PROCEDURE, A DISSECTION OCCURRED. THE LESION WAS LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD). THE PHYSICIAN DIRECT STENTED THE LESION WITH A LIBERTE MONORAIL STENT AND DEPLOYED THE STENT AT 14 ATMS. UPON DEFLATION OF THE LIBERTE BALLOON AND WHILE RETRACTING INTO THE GUIDE CATHETER (TYPE UNKNOWN) A DISSECTION WAS NOTED PROXIMAL TO THE IMPLANTED STENT. ANOTHER STENT (DRIVER) WAS DEPLOYED TO REPAIR THE DISSECTION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THIS DEVICE. ADDITIONAL INFORMATION REGARDING THIS PROCEDURE HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIBERTE MONORAIL CORONARY STENT DEL SYS CORONARY STENT SYSTEM MAF BOSTON SCIENTIFIC 16MM X 3.0MM 0008911393

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention