BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUT R TRANSCATHETER AORTIC VALVE

    MDR report key: 6344054 · Received February 20, 2017

    Report

    Report Number
    2025587-2017-00265
    Event Type
    Injury
    Date Received
    February 20, 2017
    Date of Event
    November 1, 2016
    Report Date
    January 27, 2017
    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

    CITATION: MEREDITH I ET AL. LONGEST FOLLOW-UP AFTER IMPLANTATION OF A SELF-EXPANDING REPOSITIONABLE TRANSCATHETER AORTIC VALVE. JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY. NOVEMBER 2016: 68(18): B302-B303. DOI: 10.1016/J.JACC.2016.09.162. NO UNIQUE DEVICE IDENTIFIER (SERIAL/LOT) NUMBERS WERE PROVIDED; WITHOUT THIS INFORMATION IT COULD NOT BE DETERMINED WHETHER THESE OBSERVATIONS HAVE BEEN PREVIOUSLY REPORTED. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION VIA LITERATURE REVIEW REGARDING FOLLOW-UP AFTER TRANSCATHETER AORTIC VALVE IMPLANT. ALL DATA WERE COLLECTED FROM MULTIPLE CENTERS. THE STUDY POPULATION INCLUDED 60 PATIENTS (PREDOMINANTLY FEMALE; MEAN AGE 83 YEARS), ALL OF WHICH WERE IMPLANTED WITH MEDTRONIC EVOLUTR BIOPROSTHETIC VALVE (SERIAL NUMBERS NOT PROVIDED). AMONG ALL PATIENTS FOUR DEATHS OCCURRED; NONE OF THE DEATHS WERE ATTRIBUTED TO MEDTRONIC PRODUCT. AMONG ALL PATIENTS ADVERSE EVENTS INCLUDED: TWO DISABLING STROKE, TWO MODERATE PARAVALVULAR LEAK, AND 9 PERMANENT PACEMAKER IMPLANTS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126061 EVOLUT R TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION EVOLUTR-23

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention