BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC TRANSCATHETER VALVE

    MDR report key: 12252703 · Received July 30, 2021

    Report

    Report Number
    2025587-2021-02419
    Event Type
    Injury
    Date Received
    July 30, 2021
    Date of Event
    October 13, 2020
    Report Date
    July 30, 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: KAIHARA, T. MD ET AL. EFFECT OF IMMUNOSUPPRESSIVE THERAPY ON CLINICAL OUTCOMES FOR PATIENTS WITH AORTIC STENOSIS FOLLOWING TRANSCATHETER AORTIC VALVE IMPLANTATION. CIRCULATION JOURNAL, 2021 84:2296-2301. DOI: 10.1253/CIRCJ.CJ-20-0600 EARLIEST DATE OF PUBLISH USED FOR DATE OF EVENT. MEDTRONIC PRODUCTS REFERENCED: COREVALVE, EVOLUTR AND EVOLUTPRO (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 THE EFFECT OF IMMUNOSUPPRESSIVE THERAPY IN PATIENT OUTCOMES AFTER THE IMPLANT OF A TRANSCATHETER AORTIC VALVE (TAV). ALL DATA WERE RETROSPECTIVELY COLLECTED FROM A SINGLE CENTER BETWEEN 2016 AND 2018. THE STUDY POPULATION INCLUDED 282 PATIENTS (PREDOMINANTLY FEMALE)), FORTY OF WHOM WERE IMPLANTED WITH MEDTRONIC COREVALVE, EVOLUTR OR EVOLUTPRO TAV. THE REMAINING 242 PATIENTS WERE IMPLANTED WITH A NON-MEDTRONIC BALLOON EXPANDABLE TAV. NO SERIAL NUMBERS PROVIDED. AMONG ALL PATIENTS, NO DEATHS WERE ASSOCIATED WITH A MEDTRONIC DEVICE. AMONG ALL PATIENTS, ADVERSE EVENTS INCLUDED: INFECTION, ENDOCARDITIS, NON-LETHAL MYOCARDIAL INFARCTION (MI), UNSTABLE ANGINA AND STROKE. 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
    1150186 MEDTRONIC TRANSCATHETER VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC HEART VALVES DIVISION MDT-TRANS VALVE

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L