BEUDAMED
    FDA Adverse Event Death Summary report: N

    MOSAIC MITRAL BIOPROSTHETIC HEART VALVE

    MDR report key: 1060704 · Received June 11, 2008

    Report

    Report Number
    2025587-2008-00050
    Event Type
    Death
    Date Received
    June 11, 2008
    Date of Event
    February 27, 2008
    Report Date
    May 12, 2008
    Manufacturer
    MEDTRONIC HEART VALVES, INC
    Product Code
    LWR
    PMA / PMN Number
    P990064
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY REVIEWED. RESULTS - DEVICE HISTORY REVIEW FOUND THE PRODUCT MET SPECIFICATIONS WHEN RELEASED FOR DISTRIBUTION. CONCLUSION - EXACT CAUSE OF EVENT CANNOT BE DETERMINED WITHOUT PRODUCT RETURN. ANALYSIS: TO DATE, THIS PRODUCT HAD NOT BEEN RETURNED FOR ANALYSIS. WITHOUT PRODUCT RETURN, ANALYSIS IS LIMITED TO REVIEW OF THE DEVICE HISTORY RECORD, WHICH SHOWS THAT THIS PRODUCT MET MFG SPECIFICATIONS WHEN RELEASED FOR DISTRIBUTION. CONCLUSION: NO DEFINITIVE CONCLUSIONS CAN BE DRAWN AT THIS TIME REGARDING THE PERFORMANCE OF THE DEVICE, AS THE PRODUCT HAS NOT BEEN RETURNED FOR ANALYSIS. RETURN OF THE PRODUCT, HOWEVER, IS ANTICIPATED. ONCE RECEIVED, THE DEVICE WILL BE ANALYZED, AND A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFO THAT THIS BIOPROSTHETIC MITRAL VALVE EXHIBITED MITRAL REGURGITATION APPROX 1.5 YRS POST IMPLANT. IT WAS REPORTED THAT ONE OF THE CUSPS LOCATED CLOSE TO THE LV OUTFLOW TRACK WAS PROLAPSED, AND ITS' COMMISSURE APPEARED ELONGATED. THE VALVE WAS SUBSEQUENTLY EXPLANTED AND REPLACED WITH MECHANICAL VALVE. IT WAS REPORTED THAT THE PT RECOVERED AND ATE A MEAL BY HIMSELF, BUT LATER DEVELOPED MEDIASTINITIS. THE PT'S PH BECAME DIFFICULT TO CONTROL, AND ULTIMATELY RESULTED IN MULTI-ORGAN FAILURE, RESULTING IN DEATH. THE VALVE WAS PRESERVED IN FORMALDEHYDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MOSAIC MITRAL BIOPROSTHETIC HEART VALVE LWR MEDTRONIC HEART VALVES, INC 310 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Death