BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC TRANSCATHETER VALVE

    MDR report key: 10951314 · Received December 5, 2020

    Report

    Report Number
    2025587-2020-03684
    Event Type
    Injury
    Date Received
    December 5, 2020
    Date of Event
    September 30, 2020
    Report Date
    December 4, 2020
    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: OKUYAMA K ET AL. NEW-GENERATION TRANSCATHETER AORTIC VALVES IN PATIENTS WITH SMALL AORTIC ANNULI - COMPARISON OF BALLOON- AND SELF-EXPANDABLE VALVES IN ASIAN PATIENTS. CIRC J. 2020 OCT 23;84(11):2015-2022. DOI: 10.1253/CIRCJ.CJ-20-0368. EPUB 2020 SEP 30. EARLIEST DATE OF PUBLISH USED FOR DATE OF EVENT . MEDTRONIC PRODUCTS REFERENCED: EVOLUT R (PMA# P130021, PRO CODE NPT), EVOLUT PRO (PMA# P130021, PRO 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 FROM A LITERATURE ARTICLE REGARDING A COMPARISON OF THE HEMODYNAMIC AND CLINICAL OUTCOMES BETWEEN NEW GENERATION BALLOON-EXPANDABLE AND SELF- EXPANDABLE TRANSCATHETER HEART VALVES IN ASIAN PATIENTS WITH SMALL AORTIC ANNULI. ALL DATA WERE RETROSPECTIVELY COLLECTED FROM A SINGLE JAPANESE CENTER BETWEEN JANUARY 2016 AND MARCH 2019. THE STUDY POPULATION INCLUDED 46 PATIENTS AND WAS DIVIDED INTO TWO GROUPS: BALLOON-EXPANDABLE VALVE PATIENTS (33) AND SELF-EXPANDABLE VALVE PATIENTS (13). IN THE SELF-EXPANDABLE GROUP, MEDTRONIC EVOLUT R AND EVOLUT PRO TRANSCATHETER VALVES WERE IMPLANTED (ALL FEMALE, MEAN AGE 84 YEARS, MEAN WEIGHT 46 KG). NO SERIAL NUMBERS WERE PROVIDED. IN THE SELF-EXPANDABLE GROUP, ONE DEATH OCCURRED WITHIN ONE YEAR AFTER VALVE IMPLANT DUE TO INTESTINAL OBSTRUCTION. NO FURTHER DETAILS WERE PROVIDED ABOUT THE DEATH. BASED ON THE AVAILABLE INFORMATION, MEDTRONIC PRODUCT WAS NOT DIRECTLY ASSOCIATED WITH THE DEATH. IN THE SELF-EXPANDABLE GROUP, ADVERSE EVENTS INCLUDED: NEW PERMANENT PACEMAKER IMPLANTATION, NEW LEFT BUNDLE BRANCH BLOCK, MODERATE TO SEVERE PARAVALVULAR LEAK, AND PATIENT-PROSTHESIS MISMATCH. BASED ON THE AVAILABLE INFORMATION, MEDTRONIC PRODUCT WAS 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
    1415797 MEDTRONIC TRANSCATHETER VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION MDT-TRANS VALVE

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention