BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUT R TRANSCATHETER AORTIC VALVE

    MDR report key: 6771017 · Received August 7, 2017

    Report

    Report Number
    2025587-2017-01315
    Event Type
    Injury
    Date Received
    August 7, 2017
    Date of Event
    March 23, 2017
    Report Date
    July 14, 2017
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: Y. MAENO ET AL. "TRANSCATHETER AORTIC VALVE REPLACEMENT WITH DIFFERENT VALVE TYPES IN ELLIPTIC AORTIC ANNULI" CIRCULATION JOURNAL 2017; 81: 1036¿1042. DOI: 10.1253/CIRCJ.CJ-16-1240 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. 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.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION VIA LITERATURE REGARDING TRANSCATHETER AORTIC VALVE REPLACEMENT WITH DIFFERENT VALVE TYPES IN ELLIPTIC AORTIC ANNULI. ALL DATA WERE COLLECTED FROM A SINGLE CENTER BETWEEN 2013 AND JANUARY 2016. THE STUDY POPULATION INCLUDED 737 PATIENTS (PREDOMINANTLY MALE, MEAN AGE 83 YEARS), 120 OF WHICH WERE IMPLANTED WITH MEDTRONIC COREVALVE, AND EVOLUTR (SERIAL NUMBERS NOT PROVIDED). AMONG ALL PATIENTS ADVERSE EVENTS INCLUDED: MILD PARAVALVULAR LEAK (PVL), MODERATE-SEVERE PVL REQUIRING SECOND VALVE IMPLANT, INCREASED GRADIENT, LESS EFFECTIVE ORIFICE AREA, IMPROPER SIZING, VALVE EMBOLIZATION, PACEMAKER IMPLANT NEEDED, AND MYOCARDIAL INFARCTION. BASED ON THE AVAILABLE INFORMATION, THESE ADVERSE EVENTS MAY HAVE BEEN ATTRIBUTED TO MEDTRONIC PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    552332 EVOLUT R TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION EVOLUTR-29

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention