BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUT R TRANSCATHETER AORTIC VALVE

    MDR report key: 9227013 · Received October 23, 2019

    Report

    Report Number
    2025587-2019-03251
    Event Type
    Injury
    Date Received
    October 23, 2019
    Date of Event
    May 31, 2019
    Report Date
    October 23, 2019
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: LEFEBVRE-DESJARDINS ET AL. TO TURN OVER ROCKS FOR TRANSCATHETER AORTIC VALVE REPLACEMENT: CLOSURE TIME WITH ADENOSINE DIPH OSPHATE TO SUPPORT DECISIONS IN A COMPLEX TRANSCATHETER AORTIC VALVE-IN-VALVE PROCEDURE. CAN J CARDIOL. 2019 OCT;35(10):1419.E17-1419.E20. DOI: 10.1016/J.CJCA.2019.05.030. EPUB 2019 MAY 31. EARLIEST DATE OF PUBLISH USED FOR EVENT DATE. NO UNIQUE DEVICE IDENTIFIER (SERIAL/LOT) NUMBERS WERE PROVIDED; WITHOUT THIS INFORMATION IT COULD NOT BE DETERMINED WHETHER THESE OBSERVATIONS HAVE BEEN PREVIOUSLY REPORTED. WITHOUT RETURN OF THE PRODUCT NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATIONS. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION VIA LITERATURE REGARDING AN 85 YEAR-OLD FEMALE PATIENT WITH A SEVERELY CALCIFIED AND STENOTIC AORTIC NATIVE VALVE WHO UNDERWENT IMPLANT OF A MEDTRONIC EVOLUT R BIOPROSTHETIC VALVE (NO SERIAL NUMBERS PROVIDED). DURING THE IMPLANT PROCEDURE, WHEN THE VALVE WAS PARTIALLY DEPLOYED LARGE PARAVALVULAR LEAK (PVL) OCCURRED DUE TO VALVE UNDEREXPANSION CAUSED BY THE SEVERE CALCIFICATION. THE VALVE WAS RECAPTURED AND REPOSITIONED TWO ADDITIONAL TIMES WITH NO RESOLUTION TO THE PVL. THE VALVE WAS THEN FULLY RELEASED, AND BALLOON AORTIC VALVULOPLASTY (BAV) WAS PERFORMED. INITIAL BAV RESULTED IN A MINOR IMPROVEMENT IN VALVE EXPANSION BUT STILL SHOWED SIGNIFICANT PVL. ADDITIONAL BAV DISPLACED THE VALVE FROM THE INTENDED POSITION. SUBSEQUENTLY, A NON-MEDTRONIC VALVE WAS SUCCESSFULLY IMPLANTED VALVE-IN-VALVE JUST BELOW THE POSITION OF EVOLUT R. ON POST-PROCEDURAL TRANSESOPHAGEAL ECHOCARDIOGRAM, ONLY TRACE AORTIC PVL WAS NOTED. ON POST-OPERATIVE DAY 2, TRANSTHORACIC ECHOCARDIOGRAPH SHOWED NO PVL. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1022435 EVOLUT R TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION EVOLUTR-23

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention