BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE AORTIC ROOT BIOPROSTHESIS

    MDR report key: 1982663 · Received February 1, 2011

    Report

    Report Number
    2025587-2011-00006
    Event Type
    Injury
    Date Received
    February 1, 2011
    Date of Event
    January 1, 2011
    Report Date
    January 5, 2011
    Manufacturer
    MEDTRONIC HEART VALVES, INC
    Product Code
    LWR
    PMA / PMN Number
    P970031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION 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: THE VALVE WAS RETURNED ON (B)(6) 2011 AND CONTINUES TO UNDERGO ANALYSIS. CONCLUSION: THE DEVICE HISTORY RECORD WAS REVIEWED AND SHOWED THAT THIS PRODUCT MET ALL MANUFACTURING SPECIFICATION FOR PRODUCT RELEASED FOR DISTRIBUTION. NO ISSUES WERE IDENTIFIED THAT WOULD HAVE IMPACTED THIS EVENT. UPON COMPLETION OF THE ANALYSIS, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    MEDTRONIC REC'D INFORMATION THAT THIS BIOPROSTHETIC VALVE, IMPLANTED FOR 18 MONTHS, WAS EXPLANTED DUE TO A PSEUDOANEURYSM IN THE VALVE, AS WELL AS IN BETWEEN THE VALVE AND THE ARTIFICIAL BLOOD VESSEL. THERE WERE NO ADVERSE PT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE AORTIC ROOT BIOPROSTHESIS LWR MEDTRONIC HEART VALVES, INC 995 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention