BEUDAMED
    FDA Adverse Event Death Summary report: N

    EVOLUT R TRANSCATHETER AORTIC VALVE

    MDR report key: 10566081 · Received September 22, 2020

    Report

    Report Number
    2025587-2020-02886
    Event Type
    Death
    Date Received
    September 22, 2020
    Date of Event
    August 28, 2020
    Report Date
    September 22, 2020
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: EVOLUTR-29, SERIAL/LOT #: (B)(4), UBD: 03-NOV-2021, UDI#: (B)(4). PRODUCT ANALYSIS: BOTH VALVES REMAINS IMPLANTED, THEREFORE NO PRODUCT ANALYSIS CAN BE PERFORMED. CONCLUSION: WITHOUT THE RETURN OF THE PRODUCT, NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, ON RELEASE FROM THE DELIVERY CATHETER SYSTEM (DCS), THE VALVE DISLODGED TO -3 MILLIMETER (MM) ON THE NON-CORONARY CUSP (NCC) AND 0 MM ON THE LEFT CORONARY CUSP (LCC). THE VALVE WAS CONSTRAINED AND POST DILATION WAS PERFORMED. THE VALVE DISLODGED FURTHER TO -6 MM NCC AND -3 MM LCC, AT WHICH POINT THE VALVE OCCLUDED THE RIGHT CORONARY ARTERY AND CARDIAC OUTPUT DIMINISHED. COMPRESSIONS WERE STARTED AND DEFIBRILLATION WAS PROVIDED. THE VALVE COULD NOT BE SNARED. INSTEAD, A BALLOON WAS INSERTED AND INFLATED WITHIN THE VALVE AND THE VALVE WAS PULLED UP OUT OF THE ANNULUS. AFTER RELOCATING THE VALVE, RIGHT CORONARY OCCLUSION WAS STILL NOTED. A SECOND VALVE WAS PASSED THROUGH THE FIRST VALVE AND PLACED WITHIN THE ANNULUS AT 0 MM NCC AND 2 MM LCC. IT IS UNKNOWN WHETHER THE SECOND VALVE OCCLUDED THE RIGHT CORONARY ARTERY. IT WAS NOTED THAT DURING THE PROCEDURE, VENTRICULAR FIBRILLATION CONTINUALLY OCCURRED. AT THE END OF THE PROCEDURE, THERE WAS NO CARDIAC OUTPUT AND THE PATIENT SUBSEQUENTLY DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1030445 EVOLUT R TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION EVOLUTR-29

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR Death