BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUT R TRANSCATHETER AORTIC VALVE

    MDR report key: 10111398 · Received June 2, 2020

    Report

    Report Number
    2025587-2020-01766
    Event Type
    Injury
    Date Received
    June 2, 2020
    Date of Event
    April 28, 2020
    Report Date
    June 2, 2020
    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: LANDES U ET AL. REPEAT TRANSCATHETER AORTIC VALVE REPLACEMENT FOR TRANSCATHETER PROSTHESIS DYSFUNCTION. JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY. 2020; 75(16):1882-1893. DOI: 10.1016/J.JACC.2020.02.051 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 RETROSPECTIVE ANALYSIS OF REPLACEMENT TRANSCATHETER AORTIC VALVE REPLACEMENTS (TAVR) THAT OCCURRED EITHER WITHIN OR BEYOND 1 YEAR OF THE INDEX TAVR PROCEDURE. ALL DATA WERE COLLECTED FROM MULTIPLE CENTERS VIA A REGISTRY INITIATED IN FEBRUARY 2019. THE STUDY POPULATION INCLUDED 212 PATIENTS (PREDOMINANTLY MALE, MEAN AGE 79 YEARS), 49 OF WHICH WERE IMPLANTED WITH MEDTRONIC EVOLUT R TRANSCATHETER VALVES (NO SERIAL NUMBERS PROVIDED). AMONG ALL PATIENTS, IT WAS REPORTED THAT THE 30-DAY SURVIVAL WAS 94.6% AND 98.5% FOR THE EARLY REPLACEMENT AND LATE REPLACEMENT GROUPS, RESPECTIVELY. THE 1-YEAR SURVIVAL WAS 83.6% AND 88.3% FOR THE EARLY REPLACEMENT AND LATE REPLACEMENT GROUPS, RESPECTIVELY. NO FURTHER DETAILS WERE PROVIDED ABOUT THE DEATHS, AND MULTIPLE MANUFACTURERS WERE NOTED IN THE LITERATURE. BASED ON THE AVAILABLE INFORMATION MEDTRONIC PRODUCT WAS NOT DIRECTLY ASSOCIATED WITH THE DEATHS. AMONG ALL PATIENTS, ADVERSE EVENTS INCLUDED: STROKE, MYOCARDIAL INFARCTION, CORONARY OBSTRUCTION, NEW PERMANENT PACEMAKER IMPLANTATION, HIGH GRADIENTS, AORTIC STENOSIS, MODERATE-SEVERE AORTIC REGURGITATION, VALVE MALPOSITION, VALVE MALSIZING, VALVE DEGENERATION, VALVE THROMBOSIS, ENDOCARDITIS, ANNULAR RUPTURE, CARDIAC TAMPONADE, CONVERSION TO OPEN HEART SURGERY, MAJOR VASCULAR COMPLICATION, MAJOR BLEEDING, ACUTE KIDNEY INJURY. BASED ON THE AVAILABLE INFORMATION MEDTRONIC PRODUCT MAY HAVE BEEN ASSOCIATED WITH THE ADVERSE EVENTS. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    574657 EVOLUT R TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION EVOLUTR-23

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention| S