BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HANCOCK II AORTIC BIOPROSTHETIC HEART VALVE

    MDR report key: 1004040 · Received February 22, 2008

    Report

    Report Number
    2025587-2008-00011
    Event Type
    Injury
    Date Received
    February 22, 2008
    Date of Event
    January 23, 2008
    Report Date
    January 24, 2008
    Manufacturer
    MEDTRONIC HEART VALVES, INC
    Product Code
    LWR
    PMA / PMN Number
    P980043
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: DEVICE HISTORY REVIEW FOUND THE PRODUCT MET SPECIFICATIONS WHEN RELEASED FOR DISTRIBUTION. ANALYSIS: RECEIVED IN AN ORANGE-PINK SOLUTION IN A SPECIMEN CONTAINER ENCLOSED IN A TIED OFF PLASTIC BAG. SOME OF THE SOLUTION LEAKED OUT OF THE CONTAINER. ALL LEAFLETS ARE IN THE CLOSED POSITION. ALL LEAFLETS ARE FLEXIBLE. HOLES AND ABRASIONS ALONG THE BELLY AND LUNULA OF THE LEFT AND RIGHT CUSPS APPEAR TO BE DUE TO BIAS WEAR AND/OR LONG SUTURE TAIL CONTACT. A NATURAL FENESTRATION IS NOTED ON THE LUNULA OF THE LEFT CUSP. GLISTENING OFF WHITE PANNUS REMAINS ATTACHED TO NON-CORONARY CUSP ADJACENT TO THE INFLOW MARGIN OF ATTACHMENT INTO THE NON-CORONARY LEFT INFERIOR CAPTIVE AREA AND 1 TO 2MM ONTO THE CUSP. AN UNK AMOUNT OF PANNUS APPEARS TO HAVE BEEN REMOVED FROM THE INFLOW AND OUTFLOW ASPECT OF THE VALVE. RADIOGRAPHY SHOWS NO EVIDENCE OF MINERALIZATION IN THE VALVE TISSUE. CONCLUSION: REDUCED PERFORMANCE OF THE DEVICE LIKELY RELATED TO THE HOLES IN THE LEAFLETS OF THE VALVE, WHICH APPEARS TO HAVE BEEN CAUSED BY LONG SUTURE TAILS AND BIAS WEAR. THE DEVICE WAS EXPLANTED AND REPLACED WITHOUT REPORTED PT COMPLICATION.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFO THAT THIS BIOPROSTHETIC AORTIC VALVE EXHIBITED STENOSIS WITH ELEVATED GRADIENTS (60MMHG) AND MODERATE REGURGITATION. THE DEVICE HAD BEEN IN SERVICE FOR APPROX 5 YRS. THE DECISION WAS MADE TO EXPLANT AND REPLACE THIS VALVE WITH A MECHANICAL VALVE. THERE WERE NO REPORTED PT COMPLICATIONS.

    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 83 YR Hospitalization| R