BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUT PRO TRANSCATHETER AORTIC VALVE

    MDR report key: 11394556 · Received March 1, 2021

    Report

    Report Number
    2025587-2021-00715
    Event Type
    Injury
    Date Received
    March 1, 2021
    Date of Event
    December 14, 2020
    Report Date
    March 1, 2021
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: SINGH G, LE V, WIECHMANN RJ, SCHREITER SW. SELF-EXPANDABLE TRANSCATHETER AORTIC VALVE FRAME INFOLDING: AN INCREASINGLY RECOGNIZED COMPLICATION. EJCRIM 2020;7: DOI:10.12890/2020_002100. 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 A NINETY-THREE-YEAR-OLD MALE PATIENT WITH SYMPTOMATIC SEVERE AORTIC STENOSIS AND AORTIC VALVE CALCIFICATION THAT EXPENDED FROM THE AORTIC ANNULUS TO THE LEFT VENTRICULAR OUTFLOW TRACT (LVOT) WHO UNDERWENT THE IMPLANT OF A MEDTRONIC EVOLUTPRO TRANSCATHETER AORTIC VALVE (UNIQUE DEVICE IDENTIFIER NUMBERS NOT PROVIDED). DURING THE IMPLANT THE VALVE WAS RECAPTURED TWICE. ONCE DEPLOYED, SEVERE PARAVALVULAR LEAK (PVL), INCREASED GRADIENT MEASUREMENTS (MEAN GRADIENT 33 MILLIMETERS OF MERCURY (MMHG) AND AN INFOLD WERE NOTED. SUBSEQUENTLY, A FEW DAYS AFTER THE IMPLANT A BALLOON AORTIC VALVULOPLASTY (BAV) WAS PERFORMED WHICH DECREASED THE GRADIENT TO 11 MMHG AND IMPROVED THE PVL TO MILD. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288679 EVOLUT PRO TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION EVOLUTPRO-23

    Patients

    Seq Age Sex Outcome Treatment
    1 93 YR Required Intervention