BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIBERTE' MONORAIL CORONARY STENT DELIVERY SYSTEM

    MDR report key: 1001536 · Received February 21, 2008

    Report

    Report Number
    2134265-2008-00521
    Event Type
    Injury
    Date Received
    February 21, 2008
    Date of Event
    January 10, 2008
    Report Date
    February 5, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    MAF
    PMA / PMN Number
    P040016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVAL; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFO FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    CLINICAL STUDY. SAME PATIENT AS 2134265-2008-00359. SAME CASE AS 2134265-2008-00520. IT WAS REPORTED THAT DURING 13 MONTH ANGIOGRAPHIC CONTROL, CRITICAL RESTENOSIS WAS DISCOVERED. THE LESION BEING TREATED WAS LOCATED IN THE MID AND DISTAL RIGHT CORONARY ARTERY (MID & DIST RCA). THIS WAS A STAGED PROCEDURE, OCCURRING 2 MONTHS AFTER THE FIRST PORTION WHICH OCCURRED IN 2006. THE PHYSICIAN PLACED 2 LIBERTE' BARE METAL STENTS OF UNKNOWN SIZES IN THE TARGET LESIONS. THIRTEEN MONTHS AFTER THE INDEX PROCEDURE, THE PT EXPERIENCED CRITICAL RESTENOSIS AS DIAGNOSED WITH ANGIOGRAPHIC FOLLOW-UP IN THE RCA. THE PT WAS ASYMPTOMATIC FOLLOW-UP IN THE RCA. THE PT WAS ASYMPTOMATIC WITH NORMAL ACTIVITY. THE PHYSICIAN PLACED A TAXUS LIBERTE' STENT IN EACH RESTENOSED SEGMENT. THE PT WAS DISCHARGED ON ASPIRIN 100 MG/DAY CLOPIDOGREL 75 MG/DAY, RAMIPRIL 1, 25 MG/DAY, CARVEDILOL 6, 25 MG/DAY, SIMVASTATIN 40 MG/DAY, ENOXAPARIN 40 MG SC DAILY. NO ADDITIONAL INFO IS AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R