BEUDAMED
    FDA Adverse Event Death Summary report: N

    SAFARI GUIDEWIRE

    MDR report key: 17527165 · Received August 12, 2023

    Report

    Report Number
    MW5134099
    Event Type
    Death
    Date Received
    August 12, 2023
    Report Date
    August 17, 2017
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    MDM
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    MEDTRONIC RECEIVED INFORMATION THAT DURING DEPLOYMENT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, UPON RELEASE AT 1MM BELOW THE ANNULUS, THE VALVE DISLODGED TO -2MM ON THE NON-CORONARY AND -1MM ON THE LEFT CORONARY CUSPS DURING REMOVAL OF THE DELIVERY CATHETER SYSTEM (DCS). THE PHYSICIAN REPORTED THAT THE BSI SAFARI GUIDEWIRE CONTRIBUTED TO THE NOSE CONE NOT CENTERING FOLLOWING VALVE DEPLOYMENT AND MAY HAVE CONTRIBUTED TO THE DISLODGEMENT OF THE VALVE. A SECOND TRANSCATHETER VALVE WAS IMPLANTED 5MM BELOW THE FIRST VALVE. SUBSEQUENTLY, CORONARY OCCLUSION OCCURRED AND MULTIPLE ATTEMPTS TO CANNULATE THE CORONARY ARTERIES WERE UNSUCCESSFUL. CORONARY ARTERY BYPASS (CAB) WAS PERFORMED AND THE GRAFTS WERE IMPLANTED AT 10MM ABOVE THE ANNULUS. THE PATIENT WAS TRANSFERRED IN CRITICAL CONDITION AND EXPIRED IN THE RECOVERY ROOM DUE TO CARDIOGENIC EDEMA. (B)(4). THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2182579 SAFARI GUIDEWIRE INSTRUMENT, MANUAL, SURGICAL, GENERAL USE MDM BOSTON SCIENTIFIC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown