BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOSAIC MITRAL BIOPROSTHETIC VALVE

    MDR report key: 14168823 · Received April 21, 2022

    Report

    Report Number
    2025587-2022-01052
    Event Type
    Injury
    Date Received
    April 21, 2022
    Date of Event
    November 26, 2021
    Report Date
    April 21, 2022
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    DYE
    PMA / PMN Number
    P990064
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: KURIMOTO R, ET AL. A CASE OF COMMISSURAL DEHISCENCE 13 YEARS AFTER MITRAL VALVE BIOPROSTHESIS REPLACEMENT. JOURNAL OF MEDICAL ULTRASONICS. 2022; 49: 105-106. DOI: 10.1007/S10396-021-01170-7. PUBLISHED ONLINE: 26 NOVEMBER 2021. 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 · 0

    MEDTRONIC RECEIVED INFORMATION FROM A LITERATURE CASE REPORT REGARDING A FEMALE PATIENT, STATED TO BE IN 80S (SPECIFIC AGE NOT DISCLOSED), WHO PREVIOUSLY UNDERWENT MITRAL VALVE REPLACEMENT WITH A 29 MM MEDTRONIC MOSAIC BIOPROSTHETIC VALVE (UNIQUE DEVICE IDENTIFIER NUMBER NOT PROVIDED). AT THIRTEEN YEARS POST-IMPLANT, THE PATIENT WAS HOSPITALIZED THREE TIMES FOR HEART FAILURE EXACERBATION, ALL OF WHICH RESOLVED WITH MEDICAL TREATMENT. THE PATIENT WAS ADMITTED A FOURTH TIME AND TRANSTHORACIC ECHOCARDIOGRAPHY DID NOT REVEAL THE MOSAIC VALVE BECAUSE OF PROSTHETIC STENT POST ARTIFACTS, BUT THE APPARENT DEVIATED MITRAL REGURGITATION JET AND INCREASED MITRAL INFLOW VELOCITY OVER TIME LED THE AUTHORS TO SUSPECT SEVERE MITRAL REGURGITATION DUE TO BIOPROSTHETIC VALVE INSUFFICIENCY. TRANSESOPHAGEAL ECHOCARDIOGRAPHY WAS PERFORMED AND SHOWED SEVERE MITRAL REGURGITATION, LIKELY DUE TO VALVE LEAFLET PROLAPSE OF THE MOSAIC, IN ADDITION TO MOBILE STRUCTURES ON THE LEFT VENTRICULAR SIDE OF THE MOSAIC. THERE WERE NO FEBRILE EVENTS, BLOOD CULTURES WERE NEGATIVE, AND THE MOBILE STRUCTURES WERE CONSIDERED TO BE PANNUS FORMATION. SUBSEQUENTLY, BECAUSE OF THE SEVERE MITRAL REGURGITATION, REDO MITRAL VALVE REPLACEMENT WAS PERFORMED. OBSERVATION OF THE EXPLANTED MOSAIC REVEALED THAT TWO OF THE THREE VALVE COMMISSURES HAD DETACHED FROM THE STENT POST (COMMISSURAL DEHISCENCE), AND THE ENTIRE VALVE LEAFLET WAS DEVIATED. ADDITIONALLY, THE AUTHORS NOTED THE STRUCTURE THAT APPEARED TO BE PANNUS PRE-OPERATIVELY WAS THOUGHT TO BE ONE OF THE TWO DETACHED COMMISSURES. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2340576 MOSAIC MITRAL BIOPROSTHETIC VALVE REPLACEMENT HEART-VALVE DYE MEDTRONIC HEART VALVES DIVISION 310

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Hospitalization| R