BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REPLACEMENT HEART VALVE

    MDR report key: 1905285 · Received November 22, 2010

    Report

    Report Number
    2015691-2010-14419
    Event Type
    Injury
    Date Received
    November 22, 2010
    Date of Event
    October 20, 2010
    Report Date
    October 25, 2010
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: AS RECEIVED, THE VALVE COMMISSURE 2 IS PUSHED OUT, WHICH LED TO A GAP AT THE COAPTATION REGION. IT ALSO LED TO TEARS AT THE FREE MARGINS OF LEAFLETS 1 AND 2 BY APPROXIMATELY 3MM. HEAVY CALCIFICATION IS DETECTED IN THE CUSP AREA OF ALL THREE LEAFLETS. AT THE FREE MARGINS CALCIFICATION IS HEAVY AT LEAFLET 2 AND MINIMAL TO MODERATE IN 1 AND 3. CALCIFICATION RESTRICTED MOBILITY IN THE LEAFLETS AND LED TO STENOSIS. MINIMAL HOST TISSUE OVERGROWTH ENCROACHED ONTO THE TISSUE INFLOW AND INTO THE ORIFICE AT THE GREATEST POINT BY APPROXIMATELY 2-3MM. HOST TISSUE IS MODERATE TO HEAVY AT THE STENT INFLOW AND MINIMAL AT THE STENT OUTFLOW. THE SEWING RING IS CUT AND THE WIREFORM IS EXPOSED AT THE OUTFLOW ASPECT, MOST LIKELY DUE TO EXPLANT. THE X-RAY DEMONSTRATES CALCIFICATION, AND STENT DISTORTION AT COMMISSURE 2. METHOD: X-RAY. ADDITIONAL MANUFACTURER NARRATIVE: AFTER EVALUATION, THE DEVICE WAS DISMANTLED FOR THE SERIAL NUMBER. ON (B)(6) 2011, THE DHR REVIEW WAS COMPLETED. THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE. CALCIFICATION IS A WELL RECOGNIZED FAILURE MODE OF BIOPROSTHETIC VALVES. THE MECHANISMS FOR BIOPROSTHETIC HEART VALVE TISSUE CALCIFICATION ARE NOT FULLY UNDERSTOOD. MANY FACTORS CAN CONTRIBUTE TO THE ONSET AND PROPAGATION OF CALCIFICATION INCLUDING PATIENT RELATED (E.G. PATIENT AGE, DISEASE STATE, IMMUNE STATUS, AND OTHER CO-MORBIDITIES), PHARMACOLOGICAL, AND INTRINSIC PROPERTIES OF THE VALVE ITSELF. IT IS WIDELY UNDERSTOOD THAT PATIENTS WITH CHRONIC RENAL DISEASE AND PRIOR HISTORY OF CALCIFIC STENOSIS OF THE NATIVE VALVE MAY BE PREDISPOSED TO BIOPROSTHETIC CALCIFICATION. HOST TISSUE/PANNUS GROWTH IS A COMPLEX PROCESS TRIGGERED BY THE INTERACTION BETWEEN THE HOST AND THE DEVICE AND IS HIGHLY VARIABLE AMONG PATIENTS. LITERATURE DEFINES PANNUS AS A TYPE OF SCARRING AND TISSUE IN-GROWTH. IT IS NOT CURRENTLY POSSIBLE TO PREDICT THE OCCURRENCE AND SEVERITY FOR ANY GIVEN PATIENT WITH A BIOPROSTHETIC HEART VALVE. A CERTAIN DEGREE OF HOST TISSUE GROWTH IS EXPECTED. HOWEVER, ABNORMAL OR SEVERE PANNUS GROWTH CAN EVENTUALLY AFFECT THE FUNCTION OF THE VALVE. ACCORDING TO LITERATURE, PANNUS TYPICALLY OCCURS BETWEEN 12 MONTHS TO 5 YEARS. SINCE THE MECHANISM OF HOST TISSUE GROWTH IN BIOPROSTHETIC HEART VALVES IS STILL NOT FULLY UNDERSTOOD, THE ROOT CAUSE FOR THE HOST TISSUE GROWTH FOR THIS PARTICULAR VALVE CANNOT BE DETERMINED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. THIS DEVICE IS NOT DISTRIBUTED/MARKETED/SOLD OR COMMERCIALLY AVAILABLE IN THE U.S.; HOWEVER, IT IS SIMILAR TO MODEL NO. 2800 WHICH IS MARKETED IN THE U.S. THE SERIAL NUMBER IS CURRENTLY UNKNOWN. SURGEON HAS GIVEN PERMISSION TO DISASSEMBLE THE DEVICE FOR THE SERIAL NUMBER. DHR REVIEW WILL BE DONE AS SOON AS THIS INFORMATION IS AVAILABLE. IMAGES WERE PROVIDED BY THE HOSPITAL. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THE DEVICE IS BEING RETURNED FOR EVALUATION AND THE INVESTIGATION IS ON-GOING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A DEVICE WAS EXPLANTED AFTER AN IMPLANT DURATION OF APPROXIMATELY FOUR YEARS DUE TO VALVE DEGENERATION (EARLY STENOSIS). CONDITION OF DEVICE AT EXPLANT WAS DESCRIBED AS 'VERY STIFF LEAFLETS WITH MULTIPLE CALCIFIED DEPOSITS'.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES SEE H10 06B029

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| R