BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS® PERIMOUNT® PERICARDIAL MITRAL BIOPROSTHESIS

    MDR report key: 2170558 · Received July 21, 2011

    Report

    Report Number
    2015691-2011-15895
    Event Type
    Injury
    Date Received
    July 21, 2011
    Date of Event
    June 22, 2011
    Report Date
    June 24, 2011
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: AS RECEIVED, THE VALVE EXHIBITED HEAVY CALCIFICATION IN THE CUSP AREA OF ALL THREE LEAFLETS. AT THE FREE MARGINS, CALCIFICATION WAS MODERATE IN LEAFLET 3 AND MINIMAL TO MODERATE IN LEAFLET 2. CALCIFICATION RESTRICTED MOBILITY IN THE LEAFLETS AND LED TO STENOSIS. MODERATE HOST TISSUE OVERGROWTH ENCROACHED ONTO THE TISSUE OUTFLOW AND INTO THE ORIFICE AT THE GREATEST POINT BY APPROXIMATELY 7MM. AT THE OUTFLOW ASPECT, HOST TISSUE OVERGROWTH FUSED THE FREE MARGINS OF LEAFLETS 2 AND 3 AT COMMISSURE 3 BY APPROXIMATELY 6MM. HOST TISSUE WAS MINIMAL TO MODERATE AT THE STENT OUTFLOW. THE X-RAY DEMONSTRATES CALCIFICATION. EVALUATION METHOD: X-RAY. ADDITIONAL MANUFACTURER NARRATIVE: EVALUATION CONFIRMED THE PRESENCE OF CALCIFICATION WHICH CAUSED THE REPORTED STENOSIS. HOWEVER, THE ROOT CAUSE OF CALCIFICATION CANNOT BE CONCLUSIVELY DETERMINED. 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. EVALUATION ALSO CONFIRMED THE PRESENCE OF FIBROSIS (HOST TISSUE). 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 INGROWTH. 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. THE DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND CONFIRMS THAT THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS. IT WAS REPORTED THAT THE DEVICE REMAINED IMPLANTED FOR APPROXIMATELY 106 MONTHS. BASED ON THE INFORMATION AVAILABLE, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY DURING THE MANUFACTURE OF THE DEVICE THAT MAY HAVE CONTRIBUTED TO THIS EVENT. IT IS LIKELY THAT PATIENT FACTORS SUCH AS AGE, IMMUNE STATUS AND OTHER CONDITIONS CONTRIBUTED TO THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    EVALUATION: METHOD: DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN. CONCLUSION: DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(4) VALVE EXPLANTED AFTER (B)(6) DUE TO STENOSIS. THE OPERATIVE REPORT STATED THAT THE MITRAL VALVE WAS "DIFFICULT TO DIG OUT OF THE SCARRING WHICH MAY HAVE ACCOUNTED FOR SOME OF THE FIBROSIS OF THE VALVE ITSELF." A 29 MM PORCINE VALVE WAS SIZED AND USED. AFTER THE PROCEDURE, THE PATIENT WAS TAKEN TO THE INTENSIVE CARE UNIT IN A STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS® PERIMOUNT® PERICARDIAL MITRAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 6900 1J1391

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| R