BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HANCOCK II AORTIC BIOPROSTHETIC HEART VALVE

    MDR report key: 1070924 · Received July 8, 2008

    Report

    Report Number
    2025587-2008-00052
    Event Type
    Injury
    Date Received
    July 8, 2008
    Date of Event
    May 13, 2008
    Report Date
    May 28, 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

    EVAL: DEVICE HISTORY REVIEWED. RESULTS: DEVICE HISTORY REVIEW FOUND THE PRODUCT MET SPECS WHEN RELEASED FOR DISTRIBUTION. ANALYSIS: RECEIVED IN VERY LITTLE CLEAR SOLUTION IN AN OPAQUE WHITE SPECIMEN CONTAINER ENCLOSED IN A SMALL PLASTIC BAG WRAPPED IN A LARGER PLASTIC BAG. ALL LEAFLETS ARE STIFF EXCEPT WHERE MINERALIZATION IS NOT PRESENT. EXTENSIVE TISSUE DETERIORATION RESULTING IN TEARS AND ABRASIONS DUE TO CONTACT WITH MINERALIZATION IS VISIBLE ON ALL CUSPS. REMNANTS OF GLISTENING OFF WHITE PANNUS REMAIN ATTACHED ADJACENT TO THE LEFT AND RIGHT CUSP MARGINS OF ATTACHMENT. RADIOGRAPHY SHOWS EXTENSIVE MINERALIZATION IN THE NON-CORONARY CUSP THAT EXTENDS ONTO THE FREE MARGIN AND BELLIES OF THE LEFT AND RIGHT CUSPS. CONCLUSION: REDUCED PERFORMANCE OF THE DEVICE DUE TO MINERALIZATION, A CONDITION ATTRIBUTED TO THE PT. DEVICE EXPLANTED AND REPLACED WITH NO REPORTED ADVERSE PT EFFECTS.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFO THAT THIS BIOPROSTHETIC AORTIC VALVE EXHIBITED HIGH GRADIENTS AND INSUFFICIENCY. THE DECISION WAS MADE TO EXPLANT THE VALVE. UPON EXPLANT, CALCIFICATION DEPOSITS WERE OBSERVED ON ALL VALVE LEAFLETS. ASSOCIATED WITH THE CALCIFICATION WERE SMALL HOLES WITH JAGGED BORDERS, INDICATIVE OF DEGRADATION DUE TO CALCIFICATION. THE OPERATIVE REPORT INDICATES THE DYSFUNCTION WAS TRIGGERED BY ENDOCARDITIS WHICH THE PT DEVELOPED IN 2007. THE VALVE WAS EXPLANTED AND REPLACED 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 UNK Hospitalization| R