BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HANCOOK II AORTIC BIOPROSTHETIC HEART VALVE

    MDR report key: 1233937 · Received November 14, 2008

    Report

    Report Number
    2025587-2008-00106
    Event Type
    Injury
    Date Received
    November 14, 2008
    Date of Event
    October 13, 2008
    Report Date
    November 13, 2008
    Manufacturer
    MEDTRONIC HEART VALVES, INC.
    Product Code
    LWR
    PMA / PMN Number
    P980043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS OTHER - DEVICE HISTORY REVIEW FOUND THE PRODUCT MET SPECIFICATIONS WHEN RELEASED FOR DISTRIBUTION. CONCLUSION OTHER - CAUSE OF EVENT CANNOT BE DETERMINED. ANALYSIS: UPON RECEIPT AT MEDTRONIC'S QUALITY LABORATORY, ALL CUSPS WERE IN THE CLOSED POSITION WITH SUFFICIENT DEPTH OF COAPTATION. ALL LEAFLETS ARE SLIGHTLY STIFF BUT FLEXIBLE. A SMALL ABRASION WAS NOTED IN THE LUNULA OF THE LEFT CUSP, ADJACENT TO THE NON-CORONARY LEFT COMMISSURE, WHICH APPEARED TO BE DUE TO BIAS WEAR. REMNANTS OF PANNUS REMAIN ATTACHED TO THE TISSUE AND BASE STITCHING OF THE LEFT AND RIGHT CUSPS. TRACE MINERALIZATION WAS FOUND IN THE HOST TISSUE ON THE OUTFLOW RAIL OF THE EXISTING SEWING RING ADJACENT TO THE NON-CORONARY LEFT STENT POST. CONCLUSION: UNABLE TO DETERMINE THE EXACT CAUSE OF THE PARAVALVULAR LEAK, HOWEVER, HOST TISSUE OVERGROWTH AND MINERALIZATION MAY HAVE BEEN A CONTRIBUTING FACTOR. THESE FINDINGS ARE GENERALLY CONSIDERED A PATIENT RELATED CONDITION. THE VALVE WAS EXPLANTED AND REPLACED WITHOUT REPORTED ADVERSE PATIENT EFFECTS.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT THIS VALVE WAS EXPLANTED AFTER TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) REVEALED AN INTACT VALVE WITH SIGNIFICANT PARAVALVULAR LEAKAGE. HOWEVER, INTRA-OPERATIVE ECHOCARDIOGRAPHY SHOWED MUCH LESS SIGNIFICANT LEAKAGE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| R