BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOSAIC AORTIC BIOPROSTHETIC HEART VALVE

    MDR report key: 1241508 · Received November 20, 2008

    Report

    Report Number
    2025587-2008-00107
    Event Type
    Injury
    Date Received
    November 20, 2008
    Date of Event
    October 15, 2008
    Report Date
    November 20, 2008
    Manufacturer
    MEDTRONIC HEART VALVE, INC.
    Product Code
    LWR
    PMA / PMN Number
    P990064
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL: DEVICE HISTORY REVIEWED. RESULTS CODE: DEVICE HISTORY REVIEW FOUND THE PRODUCT MET SPECIFICATIONS WHEN RELEASED FOR DISTRIBUTION. CONCLUSION CODE: THE DEVICE WAS NOT RETURNED FOR ANALYSIS. CAUSE OF EVENT CANNOT BE DETERMINED. ANALYSIS - THE SUBMITTED ANALYSIS REPORT FROM THE CLEVELAND CLINIC REPORTED THE GROSS ANALYSIS OF THE VALVE REVEALED THAT ALL 3 CUSPS WERE PRESENT. THERE WAS PANNUS FORMATION ON THE VENTRICULAR SIDE OF THE VALVE. THERE WAS ORGANIZING FIBRINOUS MATERIAL ON THE THREE CUSPS ON THE AORTIC SIDE OF THE VALVE WITH NO EVIDENCE OF ACUTE INFLAMMATION. THE VALVE WAS NOT INFECTED. CONCLUSION: THE VALVE WAS NOT RETURNED TO MEDTRONIC FOR EVALUATION. REVIEW OF THE SUBMITTED ANALYSIS REPORT INDICATED HOST TISSUE OVERGROWTH AND FIBRIN ON THE CUSPS. THE VALVE WAS EXPLANTED AND REPLACED WITHOUT REPORTED ADVERSE PATIENT EFFECTS.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION FROM THE CLINICIAN THAT THIS BIOPROSTHETIC VALVE, IMPLANTED 29 MONTHS, WAS EXPLANTED DURING REPAIR OF A THORACIC ANEURYSM.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Hospitalization| R