BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HANCOCK II AORTIC BIOPROSTHETIC HEART VALVE

    MDR report key: 1111009 · Received August 8, 2008

    Report

    Report Number
    2025587-2008-00074
    Event Type
    Injury
    Date Received
    August 8, 2008
    Date of Event
    July 10, 2008
    Report Date
    August 8, 2008
    Manufacturer
    MEDTRONIC HEART VALVES, INC.
    Product Code
    LWR
    PMA / PMN Number
    P980043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: DEVICE HISTORY REVIEWED. RESULTS: DEVICE HISTORY REVIEW FOUND THE PRODUCT MET SPECIFICATIONS WHEN RELEASED FOR DISTRIBUTION. ANALYSIS: THE DEVICE WAS RECEIVED IN A CLEAR SOLUTION, 0.2% GLUTARALDEHYDE, IN AN EXPLANT KIT. ALL LEAFLETS ARE SLIGHTLY STIFF BUT FLEXIBLE. A LARGE TEAR AND ABRASIONS IN THE RIGHT CUSP LUNULA AND FREE MARGIN ADJACENT TO THE RIGHT NON-CORONARY COMMISSURE APPEARS TO BE ASSOCIATED WITH BIAS WEAR. A SMALL PERFORATION IN THE LUNULA OF THE NON-CORONARY CUSP ADJACENT TO THE NON-CORONARY LEFT COMMISSURE APPEARS TO BE DUE TO BIAS WEAR CONTACT. PANNUS EXTENDS FROM THE TOP OF THE LEFT RIGHT STENT POST ALONG THE OUTFLOW RAIL ADJACENT TO THE RIGHT CUSP ONTO THE RIGHT NON-CORONARY STENT POST. RADIOGRAPHY SHOWS A REMNANT OF MINERALIZATION IN THE BELLY OF THE RIGHT CUSP ADJACENT TO THE CAPTIVE RIDGE. CONCLUSION: REDUCED PERFORMANCE OF THE DEVICE LIKELY ATTRIBUTED TO TISSUE WEAR ON THE BIAS CLOTH. EVALUATION OF THE DEVICE NOTED NO COMPONENT OR MANUFACTURING ANOMALY THAT WOULD HAVE CONTRIBUTED TO THE OBSERVED BIAS WEAR, SUGGESTING THAT IMPLANT ORIENTATION/PATIENT ANATOMICAL FACTORS RESULTED IN THE OBSERVED BIAS WEAR. THE DEVICE WAS EXPLANTED AND REPLACED WITH NO REPORTED ADVERSE PATIENT EFFECTS.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT THIS BIOPROSTHETIC AORTIC VALVE EXHIBITED STENOSIS AND INSUFFICIENCY AFTER APPROXIMATELY FOUR YEARS OF SERVICE. THE DECISION WAS MADE TO EXPLANT AND REPLACE THE VALVE. UPON EXPLANT, THE VALVE APPEARED SCLEROTIC, AND EXHIBITED A TEAR IN THE NON-CORONARY LEAFLET. IT WAS REPORTED THAT A HOLE OCCURRED DURING EXPLANT DUE TO A FORCEPS. THE VALVE WAS REPLACED WITH A SIMILAR DEVICE, WITH NO REPORTED ADVERSE PATIENT 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 74 YR Hospitalization| R