BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC SURGICAL TISSUE VALVE

    MDR report key: 12450280 · Received September 9, 2021

    Report

    Report Number
    2025587-2021-02773
    Event Type
    Injury
    Date Received
    September 9, 2021
    Date of Event
    May 11, 2021
    Report Date
    September 9, 2021
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    LWR
    PMA / PMN Number
    P970031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: FEIER H, GRIGORESCU A, FALNITA L, RACHITA O, GASPAR M, LUCA CT. LONG-TERM RESULTS (UP TO 20 YEARS) OF 19 MM OR SMALLER PROSTHESES IN THE AORTIC POSITION. DOES SIZE MATTER? A PROPENSITY-MATCHED SURVIVAL ANALYSIS. JOURNAL OF CLINICAL MEDICINE. 2021; 10(10):2055. HTTPS://DOI.ORG/10.3390/JCM10102055 EARLIEST DATE OF PUBLISH USED FOR DATE OF EVENT. MEDTRONIC PRODUCTS REFERENCED: FREESTYLE (PMA# P970031, PRODUCT CODE LWR) AND HANCOCK II (PMA, P980043, 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 OF SMALL PROSTHESIS IMPLANTATION IN THE AORTIC POSITION. ALL DATA WERE COLLECTED FROM A SINGLE CENTER BETWEEN 2000 AND 2018. THE STUDY POPULATION INCLUDED 670 PATIENTS (PREDOMINANTLY FEMALE, MEAN AGE 65YEARS). MEDTRONIC VALVES THAT WERE IMPLANTED INCLUDE: OPEN PIVOT (37), MED HALL (11), ADVANTAGE (4), HANCOCK II (74), AND FREESTYLE (6). THE REMAINING PATIENTS WERE IMPLANTED WITH A NON-MEDTRONIC VALVE. NO SERIAL NUMBERS WERE PROVIDED. AMONG ALL PATIENTS, NO DEATHS WERE ATTRIBUTED TO A MEDTRONIC DEVICE. AMONG ALL PATIENTS, ADVERSE EVENTS INCLUDED: PATIENT-PROSTHESIS MISMATCH (PPM), VALVE DEGENERATION. OTHER ADVERSE EVENTS INCLUDED ENDOCARDITIS AND SEVERE PARAVALVULAR LEAK (PVL) TREATED WITH REOPERATION. BASED ON THE AVAILABLE INFORMATION MEDTRONIC PRODUCT MAY HAVE BEEN 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
    1348140 MEDTRONIC SURGICAL TISSUE VALVE HEART-VALVE, NON-ALLOGRAFT TISSUE LWR MEDTRONIC HEART VALVES DIVISION MDT-TISSUE VALVE

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| R