BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC SURGICAL MECHANICAL VALVE

    MDR report key: 12350457 · Received August 20, 2021

    Report

    Report Number
    2025587-2021-02613
    Event Type
    Injury
    Date Received
    August 20, 2021
    Date of Event
    September 9, 2014
    Report Date
    August 20, 2021
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    LWQ
    PMA / PMN Number
    P990046
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: KOERTKE ET AL. TELEMEDICINE-GUIDED, VERY LOW-DOSE INTERNATIONAL NORMALIZED RATIO SELF-CONTROL IN PATIENTS WITH MECHANICAL HEART VALVE IMPLANTS. EUR HEART J. 2015 JUN 1;36(21):1297-305. DOI: 10.1093/EURHEARTJ/EHU330. EPUB 2014 SEP 9. EARLIEST DATE OF PUBLISH 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 · 1

    MEDTRONIC RECEIVED INFORMATION VIA LITERATURE REGARDING LOW-DOSE INTERNATIONAL NORMALIZED RATIO SELF-CONTROL IN PATIENTS WITH MECHANICAL HEART VALVE IMPLANTS. ALL DATA WERE COLLECTED FROM MULTIPLE CENTERS FROM JANUARY 2006 TO APRIL 2012. THE STUDY POPULATION INCLUDED 1,571 PATIENTS WHO WERE PREDOMINANTLY MALE WITH AN APPROXIMATE MEAN AGE OF 58 YEARS. MULTIPLE MANUFACTURER¿S DEVICES WERE IMPLANTED IN THE STUDY POPULATION; EIGHT PATIENTS WERE IMPLANTED WITH MEDTRONIC MECHANICAL PROSTHETIC HEART VALVES (MODEL AND/OR UNIQUE DEVICE IDENTIFIER NUMBERS WERE NOT PROVIDED). AMONG ALL PATIENTS, 29 DEATHS OCCURRED DUE TO: MYOCARDIAL INFARCTION, SEPSIS, TUMOR, SUDDEN CARDIAC DEATH, AORTIC ANEURYSM, SURGERY-RELATED BLEEDING, CARDIAC FAILURE, KIDNEY FAILURE, SEPSIS, AND MULTIPLE ORGAN FAILURE. BASED ON THE AVAILABLE INFORMATION MEDTRONIC PRODUCT WAS NOT DIRECTLY ASSOCIATED WITH THE DEATH(S). AMONG ALL PATIENTS, ADVERSE EVENTS INCLUDED: MAJOR BLEEDING COMPLICATIONS, AND THROMBOTIC EVENTS RESULTING IN STROKE, TRANSIENT ISCHEMIC ATTACK (TIA), OR ISCHEMIA. ANOTHER OUTCOME OF STENOSIS WAS STATED AS BEING UNRELATED TO A VALVE. 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
    1248067 MEDTRONIC SURGICAL MECHANICAL VALVE HEART-VALVE, MECHANICAL LWQ MEDTRONIC HEART VALVES DIVISION MDT-MECH VALVE

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Life Threatening