BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUT R TRANSCATHETER AORTIC VALVE

    MDR report key: 12464969 · Received September 13, 2021

    Report

    Report Number
    2025587-2021-02805
    Event Type
    Injury
    Date Received
    September 13, 2021
    Date of Event
    May 14, 2021
    Report Date
    September 13, 2021
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: KLECZYNSKI P, ET AL. INPATIENT CARDIAC REHABILITATION AFTER TRANSCATHETER AORTIC VALVE REPLACEMENT IS ASSOCIATED WITH IMPROVED CLINICAL PERFORMANCE AND QUALITY OF LIFE. J CLIN MED. 2021 MAY 14;10(10):2125. DOI: 10.3390/JCM10102125. 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 CLINICAL PERFORMANCE AND QUALITY OF LIFE CHANGES IN PATIENTS UNDERGOING TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) SCHEDULED DIRECTLY TO INPATIENT CARDIAC REHABILITATION COMPARED TO THOSE WHO WERE DISCHARGED HOME. ALL DATA WAS RETROSPECTIVELY COLLECTED FROM A SINGLE CENTER REGISTRY BETWEEN JANUARY 2017 AND MARCH 2018. OF THE 105 PATIENTS INCLUDED IN THE STUDY POPULATION (PREDOMINANTLY FEMALE, MEAN AGE 80 YEARS), 64 UNDERWENT TAVR WITH THE MEDTRONIC EVOLUT R. NO UNIQUE DEVICE IDENTIFIER NUMBERS WERE PROVIDED. AMONG ALL PATIENTS, APPROXIMATELY 8 ALL-CAUSE DEATHS OCCURRED DURING THE 12-MONTH FOLLOW-UP. NO STATEMENT WAS MADE SUGGESTING A CAUSAL OR CONTRIBUTORY RELATIONSHIP BETWEEN EVOLUT R AND THE DEATHS. AMONG ALL PATIENTS, ADVERSE EVENTS INCLUDED: BLEEDING COMPLICATIONS REQUIRING BLOOD TRANSFUSION; AND NEED FOR PERMANENT PACEMAKER IM PLANTATION. EVOLUT R 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
    1362305 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 Required Intervention