BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS

    MDR report key: 2572032 · Received May 11, 2012

    Report

    Report Number
    2015691-2012-17477
    Event Type
    Injury
    Date Received
    May 11, 2012
    Date of Event
    April 12, 2012
    Report Date
    April 12, 2012
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: X-RAY. THE EXPLANTED DEVICE WAS RETURNED AND EVALUATED BY EDWARDS LABORATORY WITH OBSERVATIONS AS FOLLOWS; AS EVIDENT IN THE X-RAY, THE VALVE EXHIBITED HEAVY CALCIFICATION IN THE CUSP AREA OF LEAFLET 3, AND MODERATE TO HEAVY IN THE CUSP AREAS OF LEAFLETS 1 AND 2. HEAVY CALCIFICATION WAS ALSO NOTED AT THE FREE MARGINS OF LEAFLET 2. CALCIFICATION RESTRICTED MOBILITY IN THE LEAFLETS AND LED TO STENOSIS. MOREOVER, MINIMAL HOST TISSUE OVERGROWTH ENCROACHED ONTO THE TISSUE INFLOW AND INTO THE ORIFICE AT THE GREATEST POINT BY APPROXIMATELY 2MM. HOST TISSUE WAS HEAVY AT THE STENT INFLOW AND MINIMAL AT THE STENT OUTFLOW. THE DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND CONFIRMS THAT THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS. DEVICE EVALUATION CONFIRMS CALCIFIC TISSUE DEGENERATION AS THE PRIMARY CAUSE OF THE REPORTED STENOSIS, IN ADDITION TO MODERATE HOST TISSUE OVERGROWTH (PANNUS). 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. IN THIS CASE, PATIENT'S MEDICAL HISTORY HAS NOT BEEN PROVIDED. ATTEMPTS TO OBTAIN ADDITIONAL PATIENT RECORDS AND EVENT DETAILS FROM THE HCP ARE ONGOING, HOWEVER, NO RECORDS HAVE BEEN RECEIVED TO DATE. THE AVAILABLE INFORMATION SUGGESTS NOTHING TO INDICATE A DEVICE QUALITY DEFICIENCY THAT MAY HAVE CAUSED OR CONTRIBUTED TO THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN EDWARDS AORTIC BIOPROSTHETIC VALVE MODEL WAS EXPLANTED FROM A FEMALE PATIENT AFTER AN IMPLANT DURATION OF APPROXIMATELY 5 YEARS, DUE TO STRUCTURAL VALVE DETERIORATION. IT WAS LATER REPORTED AS FOLLOWS: "DEVICE WAS EXPLANTED BECAUSE OF STENOSIS. VALVE APPEARED TO BE CALCIFIED AND TWO LEAFLETS ARE "STUCK". NO ADDITIONAL INFORMATION OR PATIENT RECORDS WERE PROVIDED BY THE HEALTHCARE PROVIDER DESPITE MULTIPLE FOLLOW-UP ATTEMPTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 3000TFX R-07F1231

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| L| R