BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOSAIC AORTIC BIOPROSTHETIC HEART VALVE

    MDR report key: 2004043 · Received February 23, 2011

    Report

    Report Number
    2025587-2011-00019
    Event Type
    Injury
    Date Received
    February 23, 2011
    Date of Event
    June 16, 2007
    Report Date
    January 24, 2011
    Manufacturer
    MEDTRONIC HEART VALVES, INC.
    Product Code
    LWR
    PMA / PMN Number
    P990064
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: DEVICE HISTORY REVIEWED. RESULTS: DEVICE HISTORY REVIEW FOUND THE PRODUCT MET SPECIFICATIONS WHEN RELEASED FOR DISTRIBUTION. CONCLUSION: CAUSE OF EVENT CANNOT BE DETERMINED. ANALYSIS: NO PRODUCT WAS RETURNED. CONCLUSION: THE DEVICE HISTORY RECORD WAS REVIEWED AND SHOWED THAT THIS VALVE MET ALL MANUFACTURING SPECIFICATION FOR PRODUCT RELEASED FOR DISTRIBUTION. NO ISSUES WERE IDENTIFIED THAT WOULD HAVE IMPACTED THIS EVENT. WITHOUT THE RETURN OF THE PRODUCT, NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATION. SHOULD THE PRODUCT BE RETURNED, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    MEDTRONIC LEGAL RECEIVED INFORMATION THAT THIS BIOPROSTHETIC VALVE, IMPLANTED 12 DAYS, WAS EXPLANTED DUE TO AN INFECTION. IT WAS REPORTED THAT THE INFECTION WAS NOT SUSPECTED TO BE RELATED TO THE VALVE.

    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 70 YR Required Intervention