BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIBERTE' CORONARY STENT DELIVERY SYSTEM

    MDR report key: 1812803 · Received August 24, 2010

    Report

    Report Number
    2134265-2010-03606
    Event Type
    Injury
    Date Received
    August 24, 2010
    Date of Event
    March 19, 2009
    Report Date
    July 28, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    MAF
    PMA / PMN Number
    P040016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). DEVICE EVALUATED BY MANUFACTURER: IT IS INDICATED THAT THE DEVICE WILL NOT 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. (B)(4).

    Description of Event or Problem · 1

    (B)(4). IT WAS REPORTED THAT FOLLOWING A STENTING TREATMENT PROCEDURE, THE PATIENT EXPERIENCED A MYOCARDIAL INFARCTION. THE INDEX PROCEDURE TREATED THE 80% STENOSED 3.0X20MM TARGET LESION LOCATED IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA). TREATMENT CONSISTED OF PRE DILATION WITH AN UNSPECIFIED BALLOON, THE PLACEMENT OF A 3.0X28MM STUDY STENT AND POST DILATION RESULTING IN 0% RESIDUAL STENOSIS. A NON TARGET LESION LOCATED IN THE RAMUS ARTERY WAS TREATED WITH A 2.5X12MM LIBERTE BARE METAL STENT. POST PROCEDURE CARDIAC ENZYMES WERE NOTED TO BE ELEVATED CONSISTENT WITH A PROTOCOL DEFINED MYOCARDIAL INFARCTION. NO ACTION WAS TAKEN TO TREAT THE EVENT AND THE EVENT RESOLVED WITHOUT RESIDUAL EFFECT. THE PATIENT WAS DISCHARGED THE NEXT DAY ON ASPIRIN AND CLOPIDOGREL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIBERTE' CORONARY STENT DELIVERY SYSTEM STENT, CORONARY MAF BOSTON SCIENTIFIC - MAPLE GROVE H7493893812250 12122805

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other