BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC SURGICAL TISSUE VALVE

    MDR report key: 19008534 · Received March 29, 2024

    Report

    Report Number
    2025587-2024-02015
    Event Type
    Injury
    Date Received
    March 29, 2024
    Date of Event
    January 10, 2022
    Report Date
    March 29, 2024
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    DYE
    PMA / PMN Number
    P870078
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: XUE Y, KOSSAR AP, ABRAMOV A, ET AL. AGE-RELATED ENHANCED DEGENERATION OF BIOPROSTHETIC VALVES DUE TO LEAFLET CALCIFICATION, TISSUE CROSSLINKING, AND STRUCTURAL CHANGES. CARDIOVASC RES. 2023;119(1):302-315. DOI:10.1093/CVR/CVAC002 EARLIEST DATE OF PUBLICATION USED FOR DATE OF EVENT. MEDTRONIC BIOPROSTHETIC SURGICAL VALVES REFERENCED: ATS (PRODUCT CODE LWR, PMA# P060025), UNSPECIFIED MEDTRONIC (PRODUCT CODE UNKNOWN, PMA# UNKNOWN), AND HANCOCK (PRODUCT CODE DYE, PMA# P870078). 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. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    LITERATURE WAS REVIEWED REGARDING THE MECHANISMS OF BIOPROSTHETIC HEART VALVE DEGENERATION IN HUMAN PATIENTS AND JUVENILE ANIMALS. THE AUTHORS ANALYZED EXPLANTED BIOPROSTHETIC HEART VALVES FROM THE HUMAN PATIENT (N = 178) AND JUVENILE SHEEP (N = 11) COHORTS, RESPECTIVELY. IN THE HUMAN PATIENT COHORT, 27 MEDTRONIC BIOPROSTHETIC VALVES WERE EXPLANTED AFTER A MEAN IMPLANT DURATION OF 7.3 YEARS DUE TO STRUCTURAL VALVE DETERIORATION (SVD). VARYING DEGREES OF CALCIFICATION WERE ALSO DETECTED IN THE EXPLANTED VALVE LEAFLETS FROM THE HUMAN PATIENT COHORT. IN THE JUVENILE SHEEP COHORT, 5 MEDTRONIC MELODY VALVES WERE EXPLANTED AFTER AN IMPLANT DURATION OF 6 WEEKS TO INVESTIGATE EARLY DEGENERATION. GLYCATION AND COLLAGEN MISALIGNMENT WERE OBSERVED (ACCORDING TO THE AUTHORS, THESE ARE EARLY HALLMARKS OF SVD). NO CALCIFICATION WAS DETECTED IN THE EXPLANTED MELODY VALVES. NO FURTHER INFORMATION PERTAINING TO MEDTRONIC PRODUCTS WAS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2583887 MEDTRONIC SURGICAL TISSUE VALVE REPLACEMENT HEART-VALVE DYE MEDTRONIC HEART VALVES DIVISION MDT-TISSUE VALVE

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| H