BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC SURGICAL TISSUE VALVE

    MDR report key: 14965552 · Received July 8, 2022

    Report

    Report Number
    2025587-2022-01878
    Event Type
    Injury
    Date Received
    July 8, 2022
    Date of Event
    March 1, 2022
    Report Date
    July 8, 2022
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    DYE
    PMA / PMN Number
    P970031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: PERSSON ET AL. COMPARISON OF LONG-TERM PERFORMANCE OF BIOPROSTHETIC AORTIC VALVES IN SWEDEN FROM 2003 TO 2018. JAMA NETWORK OPEN. 2022 MAR 1;5(3):E220962. DOI: 10.1001/JAMANETWORKOPEN.2022.0962. EARLIEST DATE OF PUBLICATION USED FOR DATE OF EVENT. MEDTRONIC PRODUCTS REFERENCED: HANCOCK II (PMA# P980043, PRODUCT CODE DYE) AND 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 · 0

    MEDTRONIC RECEIVED INFORMATION VIA LITERATURE REGARDING LONG-TERM PERFORMANCE OF BIOPROSTHETIC AORTIC VALVES IN SWEDEN. ALL DATA WERE COLLECTED FROM MULTIPLE SWEDISH CENTERS BETWEEN JANUARY 1, 2003, AND DECEMBER 31, 2018. THE STUDY POPULATION INCLUDED 16,983 PATIENTS WHO WERE PREDOMINANTLY MALE WITH A MEAN AGE OF 72.6 YEARS. MULTIPLE MANUFACTURER¿S DEVICES WERE IMPLANTED IN THE STUDY POPULATION; 1,235 PATIENTS WERE IMPLANTED WITH A MEDTRONIC MOSAIC (N=541) OR HANCOCK II (N=694) BIOPROSTHETIC VALVE. NO UNIQUE DEVICE IDENTIFIER NUMBERS WERE PROVIDED. AMONG ALL PATIENTS, 6,731 ALL-CAUSE DEATHS OCCURRED DURING THE FOLLOW-UP PERIOD. AMONG ALL MEDTRONIC VALVE PATIENTS: 22% (N=272) DEATHS AT 5 YEARS, 54% (N=667) DEATHS AT 10 YEARS, AND 82% (N=1,013) DEATHS AT 15 YEARS POST-IMPLANT. NO FURTHER DETAILS WERE PROVIDED ON THE DEATHS. THERE WAS NO STATEMENT OF CAUSAL OR CONTRIBUTORY RELATIONSHIP BETWEEN MEDTRONIC PRODUCT AND THE DEATHS. AMONG MEDTRONIC VALVE PATIENTS, ADVERSE EVENTS INCLUDED: REINTERVENTION, ARRHYTHMIA REQUIRING PERMANENT PACEMAKER IMPLANT, AND CONGESTIVE HEART FAILURE (CHF) WITH HOSPITALIZATION. 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
    1503814 MEDTRONIC SURGICAL TISSUE VALVE REPLACEMENT HEART-VALVE DYE MEDTRONIC HEART VALVES DIVISION MDT-TISSUE VALVE

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male Life Threatening| R| H