BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUT R TRANSCATHETER AORTIC VALVE

    MDR report key: 12140129 · Received July 8, 2021

    Report

    Report Number
    2025587-2021-02137
    Event Type
    Injury
    Date Received
    July 8, 2021
    Date of Event
    August 22, 2020
    Report Date
    July 8, 2021
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: LEDWOCH J ET AL. DOSE-DEPENDENT EFFECT OF RENIN-ANGIOTENSIN SYSTEM BLOCKADE FOLLOWING TRANSCATHETER AORTIC VALVE REPLACEMENT. CANADIAN JOURNAL OF CARDIOLOGY. 2021; 37:443-449. DOI: 10.1016/J.CJCA.2020.08.014. 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 PROSPECTIVE STUDY INTO THE DOSE-DEPENDENT OUTCOMES OF RENIN-ANGIOTENSIN SYSTEM INHIBITION FOLLOWING TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR). ALL DATA WERE COLLECTED FROM A SINGLE CENTER BETWEEN JANUARY 2015 AND SEPTEMBER 2019. THE STUDY POPULATION INCLUDED 323 PATIENTS (PREDOMINANTLY MALE, MEAN AGE 80.4 YEARS), 49 OF WHOM WERE IMPLANTED WITH A MEDTRONIC EVOLUT R TRANSCATHETER VALVE (UNIQUE DEVICE IDENTIFIER NUMBERS NOT PROVIDED). AMONG ALL PATIENTS, THE OVERALL 1-YEAR AND 3-YEAR SURVIVAL WAS REPORTED AS 79% AND 67%, RESPECTIVELY. NO FURTHER DETAILS ABOUT THE DEATHS WERE PROVIDED, AND NO ASSOCIATION BETWEEN THE DEATHS AND THE TRANSCATHETER VALVES WERE MADE. BASED ON THE AVAILABLE INFORMATION MEDTRONIC PRODUCT WAS NOT DIRECTLY ASSOCIATED WITH THE DEATHS. AMONG ALL PATIENTS, ADVERSE EVENTS INCLUDED: MYOCARDIAL INFARCTION, STROKE, MAJOR VASCULAR COMPLICATIONS, MAJOR/LIFE-THREATENING BLEEDING, ACUTE KIDNEY INJURY, PERMANENT PACEMAKER IMPLANTATION, REDUCED LEFT VENTRICLE EJECTION FRACTION, HEART FAILURE. 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
    1031704 EVOLUT R TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC HEART VALVES DIVISION EVOLUTR-23

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization| L| R