BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIBERTE' CORONARY STENT DELIVERY SYSTEM

    MDR report key: 1143691 · Received August 29, 2008

    Report

    Report Number
    2134265-2008-02457
    Event Type
    Injury
    Date Received
    August 29, 2008
    Date of Event
    July 31, 2008
    Report Date
    July 31, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    MAF
    PMA / PMN Number
    P040016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE ANALYSIS: 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 OF 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

    SAME EVENT AS MFR REPORT #2134265-2008-02458. IT WAS REPORTED THAT FOLLOWING A CORONARY ARTERY STENTING TREATMENT PROCEDURE THROMBOSIS OCCURRED. THE INITIAL PROCEDURE WAS EMERGENT DUE TO MYOCARDIAL INFARCTION. THE TARGET LESION WAS IN THE RIGHT CORONARY ARTERY (RCA). THE PHYSICIAN IMPLANTED A 4.0X28MM PROMUS DRUG ELUTING STENT (DES). "CLOT" WAS ASPIRATED FROM AN UNSPECIFIED LOCATION WITH AN UNSPECIFIED DEVICE AND THE PT WAS SENT TO THE ICU. AT 6 HOURS LATER, THROMBOSIS WAS DISCOVERED IN AN UNSPECIFIED LOCATION. THE PHYSICIAN IMPLANTED A "4.0" LIBERTE BARE METAL STENT (BMS) "PROXIMAL" AND A "3.5" TAXUS EXPRESS2 DES "DISTAL". THE FOLLOWING DAY, "THE ARTERY" WAS COMPLETELY CLOSED OFF AGAIN, "COLLATERAL TO LEFT SIDE GOING TO THE PDA". THE PHYSICIAN IMPLANTED A BALLOON PUMP. THE PT WAS REPORTED AS BEING "CURRENTLY STABLE". DESPITE MULTIPLE ATTEMPTS TO REQUEST ADD'L CLINICAL INFO, NO INFO HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIBERTE' CORONARY STENT DELIVERY SYSTEM MAF STENT, CORONARY MAF BOSTON SCIENTIFIC 4.0 MM

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other| R