BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC TRANSCATHETER VALVE

    MDR report key: 14552414 · Received May 31, 2022

    Report

    Report Number
    2025587-2022-01518
    Event Type
    Injury
    Date Received
    May 31, 2022
    Date of Event
    June 2, 2021
    Report Date
    May 31, 2022
    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
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: HUCZEK ET AL. TEMPORAL TRENDS OF TRANSCATHETER AORTIC VALVE IMPLANTATION IN A HIGH-VOLUME ACADEMIC CENTER OVER 10 YEARS. KARDIOL POL. 2021;79(7-8):820-826. DOI: 10.33963/KP.A2021.0030. EPUB 2021 JUN 2. EARLIEST DATE OF PUBLICATION 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 · 0

    MEDTRONIC RECEIVED INFORMATION VIA LITERATURE REGARDING TRENDS OF TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI). ALL DATA WERE COLLECTED FROM A SINGLE CENTER BETWEEN MARCH 2010 AND JULY 2019. THE STUDY POPULATION INCLUDED 506 PATIENTS WHO WERE PREDOMINANTLY FEMALE WITH A MEAN AGE OF 79.4 YEARS. MULTIPLE MANUFACTURER¿S DEVICES WERE IMPLANTED IN THE STUDY POPULATION. AMONG ALL PATIENTS 283 WERE IMPLANTED WITH A MEDTRONIC COREVALVE (N=116), EVOLUT R OR PRO (N=167) BIOPROSTHETIC VALVE. NO UNIQUE DEVICE IDENTIFIER NUMBERS WERE PROVIDED. AMONG ALL PATIENTS THERE WERE 34 ALL-CAUSE MORTALITIES WITHIN 30 DAYS OF IMPLANT. NO FURTHER DETAILS WERE PROVIDED ON THESE DEATHS. BASED ON THE AVAILABLE INFORMATION THESE DEATHS WERE NOT ASSOCIATED WITH MEDTRONIC PRODUCT. AMONG ALL PATIENTS ADVERSE EVENTS INCLUDED: MODERATE TO SEVERE PARAVALVULAR LEAK (PVL), MAJOR TO LIFE-THREATENING BLEEDING, STROKE, TRANSIENT ISCHEMIC ATTACK (TIA), 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
    1610691 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 Female Required Intervention| L