BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC SURGICAL TISSUE VALVE

    MDR report key: 12362459 · Received August 24, 2021

    Report

    Report Number
    2025587-2021-02646
    Event Type
    Injury
    Date Received
    August 24, 2021
    Date of Event
    June 30, 2020
    Report Date
    August 24, 2021
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    LWR
    PMA / PMN Number
    P970031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: BOZSO ET AL. LONG-TERM OUTCOMES FOLLOWING MECHANICAL OR BIOPROSTHETIC AORTIC VALVE REPLACEMENT IN YOUNG WOMEN. CJC OPEN. 2020 JUN 30;2(6):514-521. DOI: 10.1016/J.CJCO.2020.06.015. ECOLLECTION 2020 NOV. EARLIEST DATE OF PUBLISH USED FOR DATE OF EVENT. MEDTRONIC PRODUCTS REFERENCED: FREESTYLE (PMA# P970031, PRODUCT CODE LWR), MOSAIC (PMA# P990064, PRODUCT CODE DYE). 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 LONG-TERM OUTCOMES FOLLOWING MECHANICAL OR BIOPROSTHETIC AORTIC VALVE REPLACEMENT IN WOMEN LESS THAN 50 YEARS OLD. ALL DATA WERE COLLECTED FROM THE ALBERTA PROVINCIAL PROJECT FOR OUTCOME ASSESSMENT IN CORONARY HEART DISEASE (APPROACH) DATABASE BETWEEN JANUARY 1, 2004, AND SEPTEMBER 16, 2018. THE STUDY POPULATION INCLUDED 162 PATIENTS (FEMALE, MEAN AGE 39 YEARS). OF THOSE, 24 PATIENTS WERE IMPLANTED WITH A MEDTRONIC FREESTYLE (N=23) OR MOSAIC (N=1) BIOPROSTHETIC VALVE. NO UNIQUE DEVICE IDENTIFIER NUMBERS WERE PROVIDED. OF THE 162 PATIENTS, 114 WERE THEN PROPENSITY-MATCHED FOR FURTHER ANALYSIS. AMONG ALL PATIENTS WHO RECEIVED A BIOPROSTHETIC VALVE, 5 DEATHS OCCURRED WHICH INCLUDED NO DEATHS WITHIN 30 DAYS, ONE DEATH WITHIN ONE YEAR, AND FOUR DEATHS BEYOND ONE YEAR. NO FURTHER DETAILS WERE PROVIDED ON THESE DEATHS. BASED ON THE AVAILABLE INFORMATION MEDTRONIC PRODUCT WAS NOT DIRECTLY ASSOCIATED WITH THE DEATH(S). AMONG ALL PATIENTS WHO RECEIVED A BIOPROSTHETIC VALVE, ADVERSE EVENTS INCLUDED: NEW-ONSET ATRIAL FIBRILLATION, NEW PERMANENT PACEMAKER, SEPSIS, CARDIAC ARREST, STROKE, CONGESTIVE HEART FAILURE, INTRACRANIAL BLEEDING REQUIRING HOSPITALIZATION, AND STRUCTURAL VALVE DEGENERATION REQUIRING REPEAT AORTIC VALVE REPLACEMENT. 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
    1254914 MEDTRONIC SURGICAL TISSUE VALVE HEART-VALVE, NON-ALLOGRAFT TISSUE LWR MEDTRONIC HEART VALVES DIVISION MDT-TISSUE VALVE

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Hospitalization| L| R