BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUT R TRANSCATHETER AORTIC VALVE

    MDR report key: 10622978 · Received October 2, 2020

    Report

    Report Number
    2025587-2020-03004
    Event Type
    Injury
    Date Received
    October 2, 2020
    Date of Event
    May 16, 2020
    Report Date
    October 2, 2020
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: MARCHEL ET AL. LEFT VENTRICULAR OUTFLOW OBSTRUCTION AFTER TAVR DUE TO SYSTOLIC ANTERIOR MOTION SUCCESSFULLY TREATED WITH CARDIAC PACING. J CARDIOTHORAC VASC ANESTH. 2020 OCT;34(10):2718-2721. DOI: 10.1053/J.JVCA.2020.04.042. EPUB 2020 MAY 16. 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 A (B)(6)YEAR-OLD FEMALE PATIENT WITH SEVERE AORTIC STENOSIS WHO UNDERWENT IMPLANT OF A MEDTRONIC 29-MM EVOLUT R BIOPROSTHETIC VALVE (NO SERIAL NUMBERS PROVIDED). ONE DAY POST-IMPLANT, ECHOCARDIOGRAM DETECTED A SIGNIFICANT GRADIENT IN THE LEFT VENTRICULAR OUTFLOW TRACT (LVOT) DUE TO THE SYSTOLIC ANTERIOR MOTION OF THE MITRAL VALVE (SAM). A NEWLY DEVELOPED FIRST-DEGREE ATRIOVENTRICULAR BLOCK AND A LEFT BUNDLE BRANCH BLOCK WERE ALSO OBSERVED. SUBSEQUENTLY, AN ATRIOVENTRICULAR PACEMAKER WAS SUCCESSFULLY IMPLANTED. SEQUENTIAL PACING WITH SHORT ATRIOVENTRICULAR DELAY WAS INITIATED, RESULTING IN A SIGNIFICANT DECREASE OF THE LVOT GRADIENT. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1084504 EVOLUT R TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION EVOLUTR-29

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention