BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOSAIC AORTIC BIOPROSTHETIC HEART VALVE

    MDR report key: 20362105 · Received October 3, 2024

    Report

    Report Number
    2025587-2024-05501
    Event Type
    Injury
    Date Received
    October 3, 2024
    Date of Event
    July 1, 2024
    Report Date
    October 3, 2024
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    DYE
    PMA / PMN Number
    P990064
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: CHHATRIWALLA ET AL. A TALE OF TWO POLYMERS: BIOPROSTHETIC VALVE REMODELING VERSUS BIOPROSTHETIC VALVE FRACTURE OF MOSAIC SURGICAL VALVES TO FACILITATE VIV TAVR. CIRCULATION CARDIOVASCULAR INTERVENTIONS. 2024 JULY 1; 17(7): E014276. DOI: 10.1161/CIRCINTERVENTIONS.124.01427.  EARLIEST DATE OF PUBLICATION 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. 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. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    LITERATURE WAS REVIEWED REGARDING INTENTIONAL REMODELING VERSUS STENT FRAME FRACTURE IN BIOPROSTHETIC VALVES TO FACILITATE TRANSCATHETER AORTIC VALVE VALVE-IN-VALVE IMPLANTATION.  IN ONE CASE, A 97-YEAR-OLD FEMALE PATIENT WAS IMPLANTED WITH A MEDTRONIC 23-MM MOSAIC BIOPROSTHETIC VALVE IN THE AORTIC POSITION.  TWELVE YEARS AFTER THE MOSAIC IMPLANT PROCEDURE, ECHOCARDIOGRAPHY REVEALED LOW-FLOW AND LOW-GRADIENT BIOPROSTHETIC VALVE STENOSIS WITH AN EJECTION FRACTION OF 36%, A MEAN GRADIENT OF 29 MMHG AND A PEAK GRADIENT OF 76 MMHG.  SUBSEQUENTLY, THE PATIENT UNDERWENT A PROCEDURE IN WHICH THE MOSAIC PROSTHETIC VALVE WAS EXPANDED BY BALLOON DILATION WITHOUT FRACTURING THE STENT FRAME, AND A NON-MEDTRONIC TRANSCATHETER VALVE WAS SUCCESSFULLY IMPLANTED INSIDE THE MOSAIC VALVE.  IN ADDITION TO THIS CASE, THE PHYSICIAN/AUTHORS REFERENCED ANOTHER CASE IN WHICH A NON-MEDTRONIC 23-MM BIOPROSTHETIC VALVE WAS IMPLANTED INSIDE OF A MEDTRONIC 25-MM MOSAIC VALVE AND BOTH VALVES WERE BALLOON DILATED UNTIL THE MOSAIC BIOPROSTHETIC VALVE STENT FRAME FRACTURED.  NO FURTHER DETAILS OR ADVERSE EVENTS WERE PROVIDED ON THESE CASES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2608368 MOSAIC AORTIC BIOPROSTHETIC HEART VALVE REPLACEMENT HEART-VALVE DYE MEDTRONIC HEART VALVES DIVISION 30525

    Patients

    Seq Age Sex Outcome Treatment
    1 97 YR Female Required Intervention| H