BEUDAMED
    FDA Adverse Event Death Summary report: N

    TRANSCATHETER BIOPROSTHETIC VALVE

    MDR report key: 17527241 · Received August 12, 2023

    Report

    Report Number
    MW5134175
    Event Type
    Death
    Date Received
    August 12, 2023
    Report Date
    June 11, 2012
    Manufacturer
    NUMED, INC
    Product Code
    DYE
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, THE NORMAL PROTOCOL WAS FOLLOWED AND A STANDARD BALLOON AORTIC VALVULOPLASTY WAS CARRIED OUT USING A NUMED NUCLEUS BALLOON. DURING THE VALVULOPLASTY A PIECE OF CALCIUM CAME OFF ONE OF THE NATIVE AORTIC LEAFLETS AND OCCLUDED THE LEFT MAIN CORONARY ARTERY. THE PATIENT ARRESTED AND DIED AFTER 20 MINUTES OF CPR. (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
    764292 TRANSCATHETER BIOPROSTHETIC VALVE REPLACEMENT HEART-VALVE DYE NUMED, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown