BEUDAMED
    FDA Adverse Event Death Summary report: N

    MOSAIC AORTIC BIOPROSTHETIC HEART VALVE

    MDR report key: 5410363 · Received February 4, 2016

    Report

    Report Number
    2025587-2016-00129
    Event Type
    Death
    Date Received
    February 4, 2016
    Date of Event
    January 1, 2005
    Report Date
    January 13, 2016
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    LWR
    PMA / PMN Number
    P990064
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). TITLE: MEDTRONIC MOSAIC PORCINE BIOPROSTHESIS: INVESTIGATIONAL CENTER EXPERIENCE TO SIX YEARS CITATION: THE JOURNAL OF HEART VALVE DISEASE 2005 14:54-63 AUTHORS: W. R. ERIC JAMIESON, GUY J. FRADET, JOAN S. MACNAB, LAWRENCE H. BURR, ELIZABETH A. STANFORD, MICHAEL T. JANUSZ, JAMES G. ABEL, EVA GERMANN, ANSON CHEUG MONTH AND YEAR OF PUBLISH USED FOR EVENT DATE. NO UNIQUE DEVICE IDENTIFIER (SERIAL/LOT) NUMBERS WERE PROVIDED; WITHOUT THIS INFORMATION, IT CANNOT BE DETERMINED WHETHER THIS EVENT HAS BEEN PREVIOUSLY REPORTED.

    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 REVIEW THAT A STUDY WAS PERFORMED TO EVALUATE THE CLINICAL PERFORMANCE OF THIS BIOPROSTHETIC SURGICAL VALVE. THE STUDY TOOK PLACE AT A SINGLE CENTER IN CANADA BETWEEN 1994 AND 2000 AND INCLUDED A TOTAL OF 657 PATIENTS. THE VALVE WAS IMPLANTED IN THE AORTIC POSITION IN 415 PATIENTS, PREDOMINATELY MALE (MEAN AGE 70.5 ± 10.7 YEARS). SERIAL NUMBERS WERE NOT PROVIDED. AORTIC ELEVEN VALVE RELATED DEATHS WERE REPORTED DUE TO; ANTI-THROMBOTIC HEMORRHAGE; PROSTHETIC VALVE ENDOCARDITIS; STRUCTURAL VALVE DETERIORATION (10 MONTHS POST IMPLANT DUE TO SEVERE STENOSIS, INCREASED GRADIENT MEASUREMENTS 82 MM HG MEAN); AND A THROMBOEMBOLISM. ADVERSE EVENTS INCLUDED; PROSTHETIC VALVE ENDOCARDITIS; STRUCTURAL VALVE DETERIORATION (8 YEARS POST IMPLANT DUE TO MODERATE CALCIFICATION WITH LEAFLET TEARS); AND THROMBOEMBOLISM. IT WAS REPORTED THAT THESE ADVERSE EVENTS WERE TREATED WITH RE-OPERATION. OTHER ADVERSE EVENTS INCLUDED; THROMBOEMBOLISM, HEMORRHAGE (CONTRIBUTED TO ANTICOAGULANT/ANTIPLATELET THERAPY), STRUCTURAL VALVE DYSFUNCTION AND MINOR STROKE. ALL STROKE SYMPTOMS RESOLVED WITHIN THREE WEEKS. IT WAS REPORTED THAT THE ADVANCED AGE OF THE PATIENT POPULATION CONTRIBUTED TO THE INCIDENCE OF EARLY AND LATE THROMBOEMBOLISM. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68764 MOSAIC AORTIC BIOPROSTHETIC HEART VALVE HEART-VALVE, NON-ALLOGRAFT TISSUE LWR MEDTRONIC HEART VALVES DIVISION 30525

    Patients

    Seq Age Sex Outcome Treatment
    1 00071 YR Death| R