BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC TRANSCATHETER VALVE

    MDR report key: 12583007 · Received October 6, 2021

    Report

    Report Number
    2025587-2021-02978
    Event Type
    Injury
    Date Received
    October 6, 2021
    Date of Event
    March 12, 2021
    Report Date
    October 6, 2021
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: ONOHARA ET AL. COST ANALYSIS OF TRANSCATHETER VERSUS SURGICAL AORTIC VALVE REPLACEMENT IN OCTOGENARIANS: ANALYSIS FROM A SINGLE JAPANESE CENTER. HEART VESSELS. 2021 OCT;36(10):1558-1565. DOI: 10.1007/S00380-021-01826-X. EPUB 2021 MAR 12. EARLIEST DATE OF PUBLISH USED FOR DATE OF EVENT. MEDTRONIC PRODUCTS REFERENCED: COREVALVE AND EVOLUT R (PMA# P130021, PRODUCT CODE NPT). 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 COST ANALYSIS OF TRANSCATHETER VERSUS SURGICAL AORTIC VALVE REPLACEMENT IN OCTOGENARIANS. ALL DATA WERE COLLECTED FROM A SINGLE CENTER BETWEEN JANUARY 2011 AND JUNE 2018. THE STUDY POPULATION INCLUDED 146 PATIENTS (PREDOMINANTLY FEMALE, MEAN AGE 84.8 YEARS). MULTIPLE MANUFACTURER¿S DEVICES WERE IMPLANTED IN THE STUDY POPULATION; 34 OF THE 45 TRANSCATHETER VALVES IMPLANTED WERE A MEDTRONIC COREVALVE OR EVOLUT R BIOPROSTHETIC TRANSCATHETER VALVE (UNIQUE DEVICE IDENTIFIER NUMBERS NOT PROVIDED). AMONG ALL TRANSCATHETER VALVE PATIENTS, NO DEATHS OCCURRED. AMONG ALL TRANSCATHETER VALVE PATIENTS ADVERSE EVENTS INCLUDED: NEW ATRIAL FIBRILLATION (AFIB), AND ARRHYTHMIA REQUIRING PERMANENT PACEMAKER IMPLANT. BASED ON THE AVAILABLE INFORMATION MEDTRONIC PRODUCT MAY HAVE BEEN ASSOCIATED WITH THE ADVERSE EVENT(S). NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1482828 MEDTRONIC TRANSCATHETER VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC HEART VALVES DIVISION MDT-TRANS VALVE

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Life Threatening| R