BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIAL BIOPROSTHESIS

    MDR report key: 2895682 · Received January 3, 2013

    Report

    Report Number
    2015691-2013-19001
    Event Type
    Injury
    Date Received
    January 3, 2013
    Date of Event
    December 6, 2012
    Report Date
    December 6, 2012
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: AS RECEIVED, MODERATE TO HEAVY CALCIFICATION WAS OBSERVED IN THE CUSP AREA OF LEAFLETS 1 AND 2, HEAVY CALCIFICATION WAS OBSERVED IN THE CUSP AREA OF LEAFLET 3. THE FREE MARGINS OF LEAFLET 2 EXHIBITED HEAVY CALCIFICATION, THE FREE MARGIN OF LEAFLET 1 EXHIBITED MODERATE CALCIFICATION AND THE FREE MARGIN OF LEAFLET 3 EXHIBITED MODERATE TO HEAVY CALCIFICATION. CALCIFICATION RESTRICTED MOBILITY IN THE LEAFLETS AND LED TO STENOSIS. MOREOVER, MINIMAL TO MODERATE HOST TISSUE OVERGROWTH ENCROACHED ONTO THE TISSUE AT THE INFLOW ASPECT AND INTO THE ORIFICE AT THE GREATEST POINT BY APPROXIMATELY 5MM. MINIMAL TO MODERATE HOST TISSUE OVERGROWTH ENCROACHED ONTO THE TISSUE AT THE OUTFLOW ASPECT AND INTO THE ORIFICE AT THE GREATEST POINT BY APPROXIMATELY 4MM. HOST TISSUE WAS MINIMAL AT THE STENT INFLOW AND MINIMAL TO MODERATE AT THE STENT OUTFLOW. THE HEALTHCARE PROVIDER DECLINED TO PROVIDE ANY MEDICAL RECORDS, PATIENT HISTORY, OR ADDITIONAL INFORMATION DUE TO PATIENT PRIVACY REGULATIONS, DESPITE MULTIPLE ATTEMPTS BY EDWARDS. DEVICE EVALUATION CONFIRMS EXTENSIVE CALCIFIC TISSUE DEGENERATION AS THE PRIMARY CAUSE OF THE REPORTED STENOSIS LEADING TO THIS EXPLANT. 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. THE DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND CONFIRMS THAT THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS. THERE HAS BEEN NO INFORMATION TO SUGGEST A DEVICE QUALITY DEFICIENCY RELATED TO THIS EVENT. IT IS LIKELY THAT THE PATIENT'S AGE ((B)(6)) AND MEDICAL HISTORY MAY HAVE CONTRIBUTED TO THIS EVENT.

    Additional Manufacturer Narrative · 1

    ADDITIONAL MANUFACTURER NARRATIVE: DESPITE MULTIPLE ATTEMPTS WITH THE HEALTHCARE PROVIDER, NO ADDITIONAL INFORMATION OR MEDICAL RECORDS HAVE BEEN PROVIDED. FOLLOW UPS ARE ONGOING. THE EXPLANTED DEVICE WAS RECEIVED, HOWEVER, NOT YET EVALUATED. ADDITIONAL INFORMATION AND DEVICE EVALUATION RESULTS WILL BE PROVIDED ONCE AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) PATIENT WITH AN IMPLANTED AORTIC BIOPROSTHETIC VALVE WAS DIAGNOSED WITH STENOSIS AND CALCIFICATION, HAD THE VALVE EXPLANTED AND REPLACED AFTER AN IMPLANT DURATION OF APPROXIMATELY 3 YEARS. MULTIPLE ATTEMPTS WITH THE HEALTHCARE PROVIDER WERE UNSUCCESSFUL TO OBTAIN ANY ADDITIONAL INFORMATION OR PATIENT DETAILS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3347 CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIAL BIOPROSTHESIS HEART-VALVE, REPLACEMENT DYE EDWARDS LIFESCIENCES 2800TFX R-08F1116

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Hospitalization| L| R