BEUDAMED
    FDA Adverse Event Death Summary report: N

    MOSAIC MITRAL BIOPROSTHETIC HEART VALVE

    MDR report key: 5410385 · Received February 4, 2016

    Report

    Report Number
    2025587-2016-00130
    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

    NO EVAL EXPLAIN CODE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. 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 242 PATIENTS IN THE MITRAL POSITION (MEAN AGE 70.5 ± 9.5 YEARS). SERIAL NUMBERS WERE NOT PROVIDED. MITRAL SEVEN VALVE RELATED DEATHS WERE REPORTED DUE TO; ANTI-THROMBOTIC HEMORRHAGE; PROSTHETIC VALVE ENDOCARDITIS; STRUCTURAL VALVE DETERIORATION THREE YEARS POST IMPLANT (DUE TO SEVERE REGURGITATION, MODERATE STENOSIS AND LEAFLET RESTRICTION), NON-STRUCTURAL DYSFUNCTION AND THROMBOEMBOLISM. ADVERSE EVENTS INCLUDED; STRUCTURAL VALVE DETERIORATION (19 MONTHS POST IMPLANT DUE TO SEVERE REGURGITATION, MINIMAL CALCIFICATION, AND A LEAFLET TEAR), NON-STRUCTURAL DYSFUNCTION AND THROMBOEMBOLISM. IT WAS REPORTED THAT THESE ADVERSE EVENTS WERE TREATED WITH RE-OPERATION. OTHER ADVERSE EVENTS INCLUDED; HEMORRHAGE (CONTRIBUTED TO ANTICOAGULANT/ANTIPLATELET THERAPY) 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
    68925 MOSAIC MITRAL BIOPROSTHETIC HEART VALVE HEART-VALVE, NON-ALLOGRAFT TISSUE LWR MEDTRONIC HEART VALVES DIVISION 310

    Patients

    Seq Age Sex Outcome Treatment
    1 00071 YR Death| R