BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOSAIC AORTIC BIOPROSTHETIC HEART VALVE

    MDR report key: 1201745 · Received October 10, 2008

    Report

    Report Number
    2025587-2008-00098
    Event Type
    Injury
    Date Received
    October 10, 2008
    Date of Event
    September 10, 2008
    Report Date
    October 10, 2008
    Manufacturer
    MEDTRONIC HEART VALVES, INC.
    Product Code
    LWR
    PMA / PMN Number
    P990064
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY REVIEWED. DEVICE HISTORY REVIEW FOUND THE PRODUCT MET SPECIFICATIONS WHEN RELEASED FOR DISTRIBUTION. ANALYSIS: THE VALVE WAS RECEIVED IN A TAN SOLUTION, 0.2% GLUTARALDEHYDE, IN SEVERAL PIECES CONSISTING OF TWO STENT POSTS, A PARTIAL STENT WITH A PARTIAL LEAFLET ATTACHED, TWO PLEDGETS, AND THREE PIECES OF HOST TISSUE, THE REMAINING LEAFLET TISSUE ON ONE STENT POST, CONTAINING A COMMISSURE, APPEARS SLIGHTLY STIFF BUT FLEXIBLE. THE PARTIAL LEAFLET ON THE PARTIAL STENT IS STIFF DUE TO MINERALIZATION. TISSUE DETERIORATION AND DEGENERATION ASSOCIATED WITH MINERALIZATION WAS NOTED IN BOTH COMMISSURES. PANNUS APPEARS TO HAVE LINED THE INFLOW ORIFICE DUE TO THE REMAINING PANNUS IN THE EXISTING INFERIOR COAPTIVE AREA OF ONE STENT POST AND APPEARS TO HAVE EXTENDED ALONG THE ADJACENT MARGIN OF ATTACHMENT. THREE PIECES OF PANNUS WERE RECEIVED WITH THE VALVE REMNANTS. RADIOGRAPHIC EXAMINATION REVEALED MODERATE TO EXTENSIVE MINERALIZATION IN BOTH COMMISSURES AND THE PARTIAL LEAFLET ATTACHED TO THE PARTIAL STENT. TRACE MINERALIZATION WAS NOTED IN ONE PIECE OF HOST TISSUE. THE DEVICE HISTORY RECORD FOR THIS VALVE WAS REVIEWED AND NO ISSUES WERE NOTED THAT WOULD HAVE IMPACTED THIS EVENT. CONCLUSION: THE ANALYSIS OF THE VALVE SHOWS THAT THE EVENT WAS CAUSED BY MINERALIZATION, WHICH IS A KNOWN FAILURE MODE FOR BIOPROSTHETIC VALVES THAT IS ATTRIBUTED TO THE PATIENT.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT THIS BIOPROSTHETIC AORTIC VALVE EXHIBITED CENTRAL REGURGITATION, NOTED ON ECHO. CALCIFICATION AND CUSPAL TEARS WERE NOTED. IT WAS REPORTED THAT THE PATIENT HAD PREVIOUS INFECTIONS. THE VALVE WAS EXPLANTED AND SUCCESSFULLY REPLACED WITH NO ADVERSE PATIENT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MOSAIC AORTIC BIOPROSTHETIC HEART VALVE LWR MEDTRONIC HEART VALVES, INC. 305 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| R