BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HANCOCK II AORTIC BIOPROSTHETIC HEART VALVE

    MDR report key: 1155343 · Received September 5, 2008

    Report

    Report Number
    2025587-2008-00082
    Event Type
    Injury
    Date Received
    September 5, 2008
    Date of Event
    January 28, 2008
    Report Date
    September 5, 2008
    Manufacturer
    MEDTRONIC HEART VALVES, INC.
    Product Code
    LWR
    PMA / PMN Number
    P980043
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION METHOD: ECHOCARDIOGRAM REVIEWED. CONCLUSION: IT WAS REPORTED THAT THE PRODUCT WILL NOT BE RETURNED FOR ANALYSIS, AND ATTEMPTS TO OBTAIN DEVICE SPECIFIC INFO HAVE BEEN UNSUCCESSFUL. HOWEVER, REVIEW OF ECHOCARDIOGRAMS SUGGEST THAT THE UNDERLYING ROOT CAUSE FOR THE REPORTED HIGH GRADIENTS WAS A COMBINATION OF PT/ PROSTHESIS MISMATCH, PRESSURE RECOVERY PHENOMENON, AND TECHNICAL APPROACH TO OBTAINING DOPPLER DURING THE ECHO. MEDTRONIC CONTINUES TO MONITOR THE FIELD PERFORMANCE TO DETECT SIMILAR EVENTS.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFO THAT THE BIOPROSTHETIC AORTIC VALVE WAS EXPLANTED AFTER APPROX 1 YEAR OF SERVICE DUE TO SYMPTOMS ASSOCIATED WITH HIGH GRADIENTS. ECHOCARDIOGRAMS INDICATE THAT THE HIGH GRADIENTS WERE CAUSED BY MODERATE PT/PROSTHESIS MISMATCH, PRESSURE RECOVERY PHENOMENON, AND OVER-TRACING OF THE SPECTRAL DOPPLER ENVELOPE. NO DEGENERATION WAS VISIBLE DURING THE ECHO, THE OPENING OF ALL THREE CUSPS WAS PROPER, THE EOA (MEASURED WITH DOPPLER) WAS 1, 2 QCM. THE INFO INDICATES THE DEVICE WAS EXPLANTED AND REPLACED WITH A STENTLESS TISSUE VALVE, WITH NO REPORTED ADVERSE PT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HANCOCK II AORTIC BIOPROSTHETIC HEART VALVE LWR MEDTRONIC HEART VALVES, INC. T505 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R