BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS

    MDR report key: 3033975 · Received April 3, 2013

    Report

    Report Number
    2015691-2013-19729
    Event Type
    Injury
    Date Received
    April 3, 2013
    Date of Event
    March 5, 2013
    Report Date
    March 5, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED DEVICE WAS RETURNED TO EDWARDS, HOWEVER, EVALUATION HAS NOT YET BEEN COMPLETED. DEVICE EVALUATION RESULTS, AS WELL AS EDWARDS CONCLUSIONS, WILL BE REPORTED ONCE COMPLETED.

    Additional Manufacturer Narrative · 1

    (B)(4) = X-RAY. DEVICE EVALUATION SUMMARY: AS RECEIVED, MODERATE TO HEAVY CALCIFICATION WAS OBSERVED IN THE CUSP AREA OF LEAFLET 3, MODERATE CALCIFICATION WAS OBSERVED IN THE CUSP AREA OF LEAFLET 2 AND MINIMAL TO MODERATE CALCIFICATION WAS OBSERVED IN THE CUSP AREA OF LEAFLET 1. THE FREE MARGINS OF ALL 3 LEAFLETS EXHIBITED HEAVY CALCIFICATION. CALCIFICATION RESTRICTED MOBILITY IN THE LEAFLETS AND LED TO STENOSIS. MOREOVER, MODERATE HOST TISSUE OVERGROWTH ENCROACHED ONTO THE TISSUE AT THE INFLOW ASPECT AND INTO THE ORIFICE AT THE GREATEST POINT BY APPROXIMATELY 4MM. MINIMAL HOST TISSUE OVERGROWTH ENCROACHED ONTO THE TISSUE AT THE OUTFLOW ASPECT AND INTO THE ORIFICE AT THE GREATEST POINT BY APPROXIMATELY 1MM. HOST TISSUE WAS MODERATE AT THE STENT INFLOW AND MINIMAL AT THE STENT OUTFLOW. ADDITIONAL MANUFACTURER NARRATIVE: DEVICE EVALUATION CONFIRMS CALCIFIC TISSUE DEGENERATION AS THE PRIMARY CAUSE OF THE REPORTED STENOSIS LEADING TO THIS EXPLANT, IN ADDITION TO HOST TISSUE (PANNUS) OVERGROWTH. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA SALES THAT A SURGEON EXPLANTED AN EDWARDS AORTIC MAGNA VALVE AFTER AN IMPLANT DURATION OF APPROXIMATELY 6 YEARS DUE TO CALCIFICATION AND STENOSIS. RECORDS INDICATE, " PATIENT UNDERWENT AORTIC VALVE REPLACEMENT APPROXIMATELY SEVEN YEARS AGO FOR AORTIC ENDOCARDITIS. ON FOLLOW-UP EVALUATION, HE WAS FOUND TO HAVE SEVERE STENOSIS OF HIS PROSTHETIC AORTIC VALVE WITH ASSOCIATED SYMPTOMS. HIS PREOPERATIVE WORKUP INCLUDED CORONARY ANGIOGRAPHY WHICH ALSO DEMONSTRATED A MULTI-VESSEL CORONARY ARTERY DISEASE. THE PATIENT NOW PRESENTS ELECTIVELY FOR REDO AORTIC VALVE REPLACEMENT AND CORONARY ARTERY BYPASS GRAFTING... THE [SUBJECT VALVE] LEAFLETS WERE HEAVILY CALCIFIED AND ESSENTIALLY IMMOBILE. THERE WAS MINIMAL PANNUS IN-GROWTH. THE VALVULAR DYSFUNCTION APPEARED TO BE DUE TO SEVERE CALCIFICATION OF THE PERICARDIAL LEAFLETS...[AFTER AVR AND CABG X4] THE PATIENT WAS TRANSPORTED TO THE SURGICAL INTENSIVE CARE UNIT IN CRITICAL CONDITION WITH ONGOING IANOTROPIC AND VASOPRESSOR SUPPORT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137231 CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 3000

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| L| R