BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOSAIC MITRAL BIOPROSTHETIC HEART VALVE

    MDR report key: 5984966 · Received September 28, 2016

    Report

    Report Number
    2025587-2016-01536
    Event Type
    Injury
    Date Received
    September 28, 2016
    Date of Event
    May 11, 2015
    Report Date
    November 15, 2016
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    LWR
    PMA / PMN Number
    P990064
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: TRETTER J ET AL. SEQUENTIAL PERCUTANEOUS CLOSURE OF MITRAL PROSTHETIC PARAVALVULAR LEAK AND COMPLEX COMMUNICATING PSEUDOANEURYSMS OF THE ASCENDING AORTA AND SUBVALVAR LEFT VENTRICULAR OUTFLOW TRACT. CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS 2016; 88:150¿156. EARLIEST DATE OF PUBLISH USED FOR EVENT DATE. NO UNIQUE DEVICE IDENTIFIER (SERIAL/LOT) NUMBERS WERE PROVIDED; WITHOUT THIS INFORMATION IT COULD NOT BE DETERMINED WHETHER THESE OBSERVATIONS HAVE BEEN PREVIOUSLY REPORTED.

    Additional Manufacturer Narrative · 1

    CORRECTION OF MODEL NUMBER FROM PREVIOUSLY SUBMITTED 305 (AORTIC) TO 310 (MITRAL).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION VIA LITERATURE REGARDING A (B)(6) MALE PATIENT WITH A COMPLEX MEDICAL HISTORY INCLUDING AORTIC COARCTATION REPAIRED IN CHILDHOOD, A SPIDER BITE LEADING TO ENDOCARDITIS AND CONSEQUENT AORTIC AND MITRAL REGURGITATION REQUIRING DOUBLE VALVE REPLACEMENT, HEART FAILURE, CHRONIC KIDNEY DISEASE, AND HEPATITIS C. SEVERAL WEEKS LATER, A SECOND AORTIC VALVE WAS PERFORMED WITH A HOMOGRAFT FOR REINFECTION AND EROSION OF THE ANNULUS, ALONG WITH REPAIR OF A LEFT VENTRICLE TO RIGHT ATRIAL SHUNT AND MITRAL PARAVALVULAR LEAK (PVL). THE PATIENT THEN DEVELOPED AN ASCENDING AORTIC PSEUDOANEURYSM AND RECURRENT MODERATE MITRAL PVL THAT WAS ADDRESSED WITH REDO MITRAL VALVE REPLACEMENT INCLUDING IMPLANT OF A MEDTRONIC 25-MM MOSAIC BIOPROSTHETIC VALVE (SERIAL NUMBER NOT PROVIDED). APPROXIMATELY FOUR YEARS LATER, THE PATIENT WAS HOSPITALIZED FOR WORSENING HEART FAILURE SYMPTOMS. DIAGNOSTIC TESTING REVEALED SEVERE MITRAL PVL WITH RIGHT VENTRICULAR DYSFUNCTION AND TWO LARGE ASCENDING AORTIC PSEUDOANEURYSMS. OVER THE COURSE OF THE NEXT FEW MONTHS THE PATIENT THEN UNDERWENT A SERIES OF PERCUTANEOUS CLOSURE PROCEDURES TO ADDRESS THE MITRAL PROSTHETIC PVL AND COMPLEX COMMUNICATING ASCENDING AORTIC AND SUBVALVAR LEFT VENTRICULAR OUTFLOW TRACT (LVOT) PSEUDOANEURYSMS. NO FURTHER INFORMATION WAS PROVIDED REGARDING THE MITRAL BIOPROSTHETIC VALVE, AND PRESUMABLY REMAINED IMPLANTED THROUGHOUT THESE INTERVENTIONS. AT A SEVEN MONTH FOLLOW-UP THE PATIENT WAS NOTED AS CLINICALLY WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    637172 MOSAIC MITRAL BIOPROSTHETIC HEART VALVE HEART-VALVE, NON-ALLOGRAFT TISSUE LWR MEDTRONIC HEART VALVES DIVISION 310

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Hospitalization| L| R