BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIBERTE MONORAIL CORONARY STENT DELIVERY SYSTEM

    MDR report key: 1040497 · Received May 9, 2008

    Report

    Report Number
    2134265-2008-01363
    Event Type
    Injury
    Date Received
    May 9, 2008
    Date of Event
    January 22, 2007
    Report Date
    April 18, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MAF
    PMA / PMN Number
    P040016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL BE RETURNED FOR EVALUATION; 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 INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    SAME CASE AS MFR REPORT #: REGISTRY. IT WAS REPORTED THAT 168 DAYS FOLLOWING A CORONARY ARTERY STENTING PROCEDURE, THE PT EXPERIENCED RESTENOSIS. THE INDEX PROCEDURE TREATED ONE LONG LESION OF THE PROXIMAL TO DISTAL RCA (RIGHT CORONARY ARTERY). THE LESION WAS A CHRONIC TOTAL OCCLUSION MEASURING 2.75X68MM WITH MILD TORTUOSITY. PREDILATION USING ANOTHER MANUFACTURER'S 2.0X12MM BALLOON WAS PERFORMED AND THREE STENTS WERE PLACED: ONE 2.75X20MM TAXUS LIBERTE DRUG ELUTING STENT AND TWO LIBERTE BARE METAL STENTS (2.75X28MM AND 3.5X32MM). IT IS UNK IN WHAT ORDER THE STENTS WERE PLACED. FOLLOWING POST DILATION USING ANOTHER MANUFACTURER'S 2.0X12MM BALLOON, THERE WAS 20% RESIDUAL STENOSIS. THE PT WAS DISCHARGED ONE DAY POST PROCEDURE ON ASA AND PLAVIX. IT WAS REPORTED THAT 168 DAYS FOLLOWING THE INDEX PROCEDURE, RESTENOSIS OF THE LIBERTE BARE METAL STENTS OCCURRED. THE 90% STENOSIS WAS TREATED WITH A TAXUS LIBERTE DRUG ELUTING STENT RESULTING IN 10% RESIDUAL STENOSIS. THE EVENT IS REPORTED AS RESOLVED. THE PT WAS TAKING ASA AND PLAVIX AT THE TIME OF THE EVENT.

    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 8569821

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention