BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOSAIC AORTIC BIOPROSTHETIC HEART VALVE

    MDR report key: 11008771 · Received December 15, 2020

    Report

    Report Number
    2025587-2020-03788
    Event Type
    Injury
    Date Received
    December 15, 2020
    Date of Event
    February 21, 2020
    Report Date
    December 14, 2020
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    DYE
    PMA / PMN Number
    P990064
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: MAK M ET AL. INTENTIONAL FRACTURE OF THE BIOPROSTHETIC VALVE RING DURING TRANSCATHETER AORTIC VALVE IMPLANTATION. KARDIOL POL. 2020 FEBRUARY; 78(4): 352-353. DOI:10.33963/KP.15208. PUBLISHED ONLINE: FEBRUARY 21, 2020. EARLIEST DATE OF PUBLISH 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. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION FROM A LITERATURE CASE REPORT REGARDING AN (B)(6)-YEAR-OLD FEMALE PATIENT WHO PREVIOUSLY UNDERWENT IMPLANT OF A 19 MM MEDTRONIC MOSAIC SURGICAL AORTIC VALVE (SERIAL NUMBER NOT PROVIDED). BETWEEN TWO AND THREE YEARS FOLLOWING MOSAIC IMPLANT, PROGRESSIVE DYSPNEA, HEART FAILURE SYMPTOMS, AND INCREASED MEAN/PEAK PRESSURE GRADIENTS (38/75 MM HG) WERE OBSERVED. SUBSEQUENTLY, THE PATIENT WAS REFERRED FOR TRANSCATHETER VALVE-IN-VALVE REPLACEMENT TO BE FOLLOWED BY INTENTIONAL BIOPROSTHETIC VALVE FRACTURE OF THE MOSAIC VALVE RING. A 23 MM MEDTRONIC EVOLUT R TRANSCATHETER VALVE (SERIAL NUMBER NOT PROVIDED) WAS IMPLANTED VALVE-IN-VALVE INSIDE THE MOSAIC. IMMEDIATELY FOLLOWING EVOLUT R IMPLANT, ECHOCARDIOGRAPHY REVEALED A DECREASE IN PRESSURE GRADIENTS (MAXIMUM/MEAN OF 23/11 MM HG). THEN, A 20 MM NON-MEDTRONIC BALLOON WAS DILATED WITH PRESSURE OF 20 ATMOSPHERE UNTIL THE MOSAIC VALVE RING CRACKED. AFTER THE PROCEDURE, ECHOCARDIOGRAPHY DETECTED A MAXIMUM/MEAN PRESSURE GRADIENT OF 17/8 MM HG. THE PATIENT WAS TRANSFERRED TO THE POST-OPERATIVE CARE UNIT IN GOOD CONDITION AND WAS DISCHARGED FIVE DAYS LATER WITH NOTABLE IMPROVEMENT OF HER HEART FAILURE SYMPTOMS. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1476898 MOSAIC AORTIC BIOPROSTHETIC HEART VALVE HEART-VALVE, REPLACEMENT DYE MEDTRONIC HEART VALVES DIVISION 30519

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention