BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUT R TRANSCATHETER AORTIC VALVE

    MDR report key: 12205104 · Received July 21, 2021

    Report

    Report Number
    2025587-2021-02337
    Event Type
    Injury
    Date Received
    July 21, 2021
    Date of Event
    March 14, 2019
    Report Date
    July 21, 2021
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: BOB-MANUEL T, ET AL. CORRELATION BETWEEN AORTIC ANGULATION AND OUTCOMES OF TRANSCATHETER AORTIC VALVE REPLACEMENT WITH NEW-GENERATION VALVES. CURR PROBL CARDIOL. 2021 FEB;46(2):100415. DOI: 10.1016/J.CPCARDIOL.2019.03.004. EPUB 2019 MAR 14. EARLIEST DATE OF PUBLISH USED FOR DATE OF EVENT. 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 FROM A LITERATURE ARTICLE REGARDING THE IMPACT OF AORTIC ANGULATION ON OUTCOMES FOLLOWING TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) WITH NEW GENERATION TRANSCATHETER VALVES. ALL DATA WAS RETROSPECTIVELY COLLECTED FROM A SINGLE CENTER BETWEEN 2012 AND 2017. OF THE 179 PATIENTS INCLUDED IN THE STUDY POPULATION, 52 PATIENTS UNDERWENT TAVR WITH THE MEDTRONIC EVOLUT R SELF-EXPANDABLE VALVE SYSTEM (PREDOMINANTLY FEMALE, MEAN AGE 79 YEARS, 86.5% CAUCASIAN). NO UNIQUE DEVICE IDENTIFIER NUMBERS WERE PROVIDED. AMONG ALL EVOLUT R PATIENTS, THE 30-DAY, 6-MONTH, AND 1-YEAR MORTALITY RATES WERE 4.1%, 4.3%, AND 4.5%, RESPECTIVELY. THE CIRCUMSTANCES OF THE DEATHS WERE NOT DISCLOSED, AND THERE WAS NO EVIDENCE SUGGESTING A CORRELATION BETWEEN MEDTRONIC PRODUCT AND THE DEATHS. AMONG ALL EVOLUT R PATIENTS, ADVERSE EVENTS INCLUDED: PERMANENT PACEMAKER IMPLANTATION; VALVE-IN-VALVE IMPLANTATION FOR UNSPECIFIED REASON; MILD AORTIC REGURGITATION (GRADE 1 OR 2); RE-HOSPITALIZATION FOR CARDIAC CAUSES; AND VENTRICLE PERFORATION (NO INTERVENTION WAS REPORTED TO HAVE BEEN PERFORMED AS A RESULT). NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1099270 EVOLUT R TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC HEART VALVES DIVISION EVOLUTR-23

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization| R