BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC TRANSCATHETER VALVE

    MDR report key: 12072456 · Received June 26, 2021

    Report

    Report Number
    2025587-2021-02006
    Event Type
    Injury
    Date Received
    June 26, 2021
    Date of Event
    April 12, 2019
    Report Date
    June 26, 2021
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: NANDA, A., ET AL. A COMPARATIVE ANALYSIS OF MITRACLIP VERSUS MITRAL VALVE-IN-VALVE REPLACEMENT FOR HIGH-RISK PATIENTS WITH SEVERE MITRAL REGURGITATION AFTER TRANSCATHETER AORTIC VALVE REPLACEMENT. CURR PROBL CARDIOL. 2021 FEB;46(2):100423. PMID: 31064671DOI: 10.1016/J.CPCARDIOL.2019.04.003. EPUB 2019 APR 12 EARLIEST DATE OF PUBLISH USED FOR DATE OF EVENT. [MEDTRONIC PRODUCTS REFERENCED: COREVALVE, EVOLUT R (PMA# P130021, PRODUCT CODE: NPT). EARLIEST APPROVED PRODUCT USED FOR PRODUCT CODE AND PMA#.] 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 TREATMENT OF MITRAL REGURGITATION AFTER TRANSCATHETER AND SURGICAL AORTIC VALVE REPLACEMENT (TAVR/SAVR). ALL DATA WERE COLLECTED FROM AN ELECTRONIC LITERATURE DATABASE ANALYSIS COVERING ARTICLES PUBLISHED BETWEEN 2012 AND 2017. THE STUDY POPULATION INCLUDED 67 PATIENTS (PREDOMINANTLY FEMALE, MEAN AGE 79 YEARS), 26 OF WHICH WERE IMPLANTED WITH MEDTRONIC COREVALVE BIOPROSTHETIC VALVES WITH AN ADDITIONAL PATIENT IMPLANTED WITH A MEDTRONIC EVOLUT R BIOPROSTHETIC VALVE (UNIQUE DEVICE IDENTIFIER NUMBERS NOT PROVIDED). AMONG ALL PATIENTS, FOUR PATIENTS DIED WITHIN 30 DAYS AND 15 PATIENTS DIED WITHIN ONE YEAR OF MITRAL VALVE REPLACEMENT. NO FURTHER INFORMATION WAS PROVIDED. BASED ON THE AVAILABLE INFORMATION MEDTRONIC PRODUCT WAS NOT DIRECTLY ASSOCIATED WITH THE DEATHS. AMONG ALL PATIENTS, ADVERSE EVENTS INCLUDED: STROKES. BASED ON THE AVAILABLE INFORMATION MEDTRONIC PRODUCT MAY HAVE BEEN ASSOCIATED WITH THE ADVERSE EVENT. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    969317 MEDTRONIC TRANSCATHETER VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC HEART VALVES DIVISION MDT-TRANS VALVE

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Other