BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC SURGICAL TISSUE VALVE

    MDR report key: 12870235 · Received November 24, 2021

    Report

    Report Number
    2025587-2021-03578
    Event Type
    Injury
    Date Received
    November 24, 2021
    Date of Event
    August 1, 2021
    Report Date
    November 24, 2021
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    DYE
    PMA / PMN Number
    P990064
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: WEI P, ET AL. A NOVEL ALTERNATIVE: TRANSAPICAL TRANSCATHETER MITRAL VALVE-IN-VALVE IMPLANTATION USING J-VALVE FOR FAILED BIOPROSTHESIS. J THORAC DIS. 2021 AUG;13(8):5055-5063. DOI: 10.21037/JTD-21-975. EARLIEST DATE OF PUBLISH USED FOR DATE OF EVENT: AUGUST 1, 2021 (MONTH AND YEAR VALID). MEDTRONIC PRODUCTS REFERENCED: HANCOCK II (PMA# P980043, PRODUCT CODE DYE), 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 FROM A LITERATURE ARTICLE REGARDING TRANSAPICAL TRANSCATHETER MITRAL VALVE-IN-VALVE IMPLANTATION TO TREAT FAILED MITRAL BIOPROSTHESES. ALL DATA WAS COLLECTED FROM A SINGLE CENTER BETWEEN MAY 2020 AND JANUARY 2021. OF THE 21 PATIENTS INCLUDED IN THE STUDY POPULATION, 12 (PREDOMINANTLY MALE, MEAN AGE 76.8 YEARS) WERE PREVIOUSLY IMPLANTED WITH A MEDTRONIC BIOPROSTHETIC MITRAL VALVE: HANCOCK II (11) OR MOSAIC (1). NO UNIQUE DEVICE IDENTIFIER NUMBERS WERE PROVIDED. THE IMPLANT DURATION OF THE MEDTRONIC BIOPROSTHETIC MITRAL VALVES RANGED FROM 8 TO 14 YEARS (MEAN 10.9 YEARS). ALL MEDTRONIC BIOPROSTHETIC MITRAL VALVE PATIENTS UNDERWENT TRANSCATHETER VALVE-IN-VALVE REPLACEMENT WITH THE NON-MEDTRONIC J-VALVE SYSTEM. THE MECHANISMS OF MITRAL VALVE FAILURE WERE SEVERE MITRAL REGURGITATION, SEVERE MITRAL STENOSIS, OR MIXED REGURGITATION/STENOSIS. PRIOR TO PERFORMING VALVE-IN-VALVE REPLACEMENT, THE AUTHORS ALSO OBSERVED THE FOLLOWING ADVERSE EFFECTS: HEART FAILURE, ELEVATED GRADIENTS, AND PULMONARY HYPERTENSION. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1769630 MEDTRONIC SURGICAL TISSUE VALVE REPLACEMENT HEART-VALVE DYE MEDTRONIC HEART VALVES DIVISION MDT-TISSUE VALVE

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male Required Intervention| H