BEUDAMED
    FDA Adverse Event Death Summary report: N

    EVOLUT R TRANSCATHETER AORTIC VALVE

    MDR report key: 8348212 · Received February 18, 2019

    Report

    Report Number
    2025587-2019-00626
    Event Type
    Death
    Date Received
    February 18, 2019
    Date of Event
    January 28, 2019
    Report Date
    February 18, 2019
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    UDI-DI
    00763000017668
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS: THE DEVICE 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, INTO A NON-MEDTRONIC SURGICAL VALVE, THERE WERE CORONARY CONCERNS REGARDING THE HEIGHT OF THE SURGICAL VALVE AND HEIGHT OF THE SINUS OF VALSALVA (SOV) THAT WERE DISCUSSED PRIOR TO THE IMPLANT PROCEDURE. THE VALVE WAS IMPLANTED AT A DEPTH OF APPROXIMATELY 1MM ON THE NON-CORONARY CUSP (NCC) AND 2MM ON THE LEFT CORONARY CUSP (LCC). DURING IMPLANT, AN OCCLUSION OF THE RIGHT CORONARY ARTERY WAS REPORTED. THE GUIDEWIRE WAS PLACED INTO THE RIGHT CORONARY ARTERY; THE RIGHT CORONARY ARTERY HAD TWO STENTS PLACED BEHIND THE SURGICAL VALVE LEAFLETS, AND THE ARTERY WAS PATENT. THE PHYSICIAN BELIEVED THE OCCLUSION WAS DUE TO THE LEAFLET ON THE SURGICAL VALVE. LATER THAT DAY, THE PATIENT BECAME HEMODYNAMICALLY UNSTABLE. AN ANGIOGRAPHY SHOWED AN OCCLUSION ON THE RIGHT CORONARY ARTERY. CARDIAC SURGERY OF THE CORONARY ARTERY WAS ATTEMPTED; HOWEVER, IT WAS UNSUCCESSFUL AND THE PATIENT DIED. IT IS UNKNOWN WHAT CAUSED THE OCCLUSION. IT WAS REPORTED THAT THERE WAS NO PROBLEM WITH THE MEDTRONIC VALVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    141081 EVOLUT R TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION EVOLUTR-26-US NA 00763000017668

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Death