BEUDAMED
    FDA Adverse Event Death Summary report: N

    EVOLUT R TRANSCATHETER AORTIC VALVE

    MDR report key: 7354306 · Received March 20, 2018

    Report

    Report Number
    2025587-2018-00625
    Event Type
    Death
    Date Received
    March 20, 2018
    Date of Event
    February 26, 2018
    Report Date
    March 20, 2018
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REMAINS IMPLANTED, THEREFORE NO PRODUCT ANALYSIS CAN BE PERFORMED. WITHOUT RETURN OF THE DEVICE, A CONCLUSIVE CAUSE CANNOT BE DETERMINED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT FOLLOWING SUCCESSFUL THE IMPLANT OF THIS 29 MM TRANSCATHETER BIOPROSTHETIC VALVE, SEVERE PARAVALVULAR LEAK (PVL) WAS NOTED STRETCHING FROM RIGHT CORONARY CUSP (RCC) TO LCC. A BALLOON AORTIC VALVULOPLASTY (BAV) WAS PERFORMED AND ELIMINATED THE PVL. IMMEDIATELY FOLLOWING THE BAV, A PERICARDIAL EFFUSION WAS REPORTED WHICH WAS THOUGHT TO BE CAUSED BY AN ANNULAR RUPTURE DURING THE BAV. SUBSEQUENTLY THE BLOOD PRESSURE DROPPED AND REANIMATION WAS INITIATED. A VIABLE BLOOD PRESSURE WAS MAINTAINED BY REPEATEDLY REDUCING THE PRESSURE WITHIN THE EPICARDIAL SAC THROUGH BLOOD EXTRACTION WITH A SYRINGE. THROUGHOUT THE DAY, THE PATIENT WAS CONSCIOUS AND THE EFFUSION WAS STABILIZED AND STOPPED. THROUGHOUT THE COURSE OF THE NIGHT, THE PATIENT DETERIORATED AND EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    197117 EVOLUT R TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION EVOLUTR-29

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Death