BEUDAMED
    FDA Adverse Event Death Summary report: N

    VERIFLEX (LIBERTE) CORONARY STENT DELIVERY SYSTEM

    MDR report key: 2040138 · Received April 5, 2011

    Report

    Report Number
    2134265-2011-00961
    Event Type
    Death
    Date Received
    April 5, 2011
    Report Date
    March 8, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    MAF
    PMA / PMN Number
    P040016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MANUFACTURER - THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE ROOT CAUSE IS ANTICIPATED PROCEDURAL COMPLICATIONS AS THIS EVENT IS A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE AND IS NOTED WITHIN THE DFU. (B)(4)

    Description of Event or Problem · 1

    SAME CASE AS MFR# 2134265-2011-00962, 2134265-2011-00963. IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, A PATIENT DEATH OCCURRED. ACCESSED WAS GAINED THROUGH THE RIGHT FEMORAL ARTERY. A 6FR FL4 RUNWAY GUIDE CATHETER WAS USED. THE LESION BEING TREATED WAS LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE PHYSICIAN REMOVED 'A LOT' OF THROMBUS USING A NON-BSC THROMBECTOMY ASPIRATION CATHETER. THE VESSEL WAS HAZY. THE PHYSICIAN DEPLOYED A 3.5X12MM VERIFLEX STENT IN THE PROXIMAL LESION. THEN ATTEMPTED TO DEPLOY A SECOND 3.5X12MM VERIFLEX STENT, BUT WAS UNABLE TO CROSS THE LESION. THE PATIENT WENT INTO CARDIOGENIC SHOCK AND PATIENT DEATH OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERIFLEX (LIBERTE) CORONARY STENT DELIVERY SYSTEM STENT, CORONARY MAF BOSTON SCIENTIFIC - GALWAY H7493893412350 0013739959

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Death EXPORT THROMBECTOMY ASPIRATION CATHETER DEVICE| 3.5X12MM VERIFLEX| ASAHI WIRE| RUNWAY GUIDE FL4 6 FR.