BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS

    MDR report key: 3133719 · Received May 29, 2013

    Report

    Report Number
    2015691-2013-20180
    Event Type
    Injury
    Date Received
    May 29, 2013
    Date of Event
    April 3, 2013
    Report Date
    April 29, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE NOT RETURNED. UNFORTUNATELY, THE EXPLANTED DEVICE WAS NOT RETURNED TO EDWARDS FOR ANALYSIS; THEREFORE, THE ROOT CAUSE OF THIS EVENT COULD NOT BE CONFIRMED. THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS. ALTHOUGH THE ROOT CAUSE CANNOT BE CONCLUSIVELY DETERMINED, IT APPEARS THAT THE PANNUS OVERGROWTH AND CALCIFICATION LIKELY CAUSED THE PATIENT'S STENOSIS. 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. 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. NO FURTHER ACTIONS ARE POSSIBLE WITH THE AVAILABLE INFORMATION.

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: AS RECEIVED, LEAFLET 2 AND LEAFLET 3 HAD A CUT AREAS REMOVED. CUT SECTIONS WERE NOT RETURNED WITH THE VALVE. HEAVY CALCIFICATION WAS OBSERVED IN THE REMAINING CUSP AREAS OF LEAFLETS 2 AND 3, MODERATE CALCIFICATION WAS OBSERVED IN THE CUSP AREA OF LEAFLET 1. THE FREE MARGINS OF ALL THREE LEAFLETS EXHIBITED MINIMAL TO MODERATE CALCIFICATION. CALCIFICATION RESTRICTED MOBILITY IN THE LEAFLETS AND LED TO STENOSIS. MODERATE TO HEAVY HOST TISSUE OVERGROWTH ENCROACHED ONTO THE TISSUE AT THE OUTFLOW ASPECT AND INTO THE ORIFICE. HEAVY HOST TISSUE OVERGROWTH ENCROACHED ONTO THE TISSUE AT THE INFLOW ASPECT AND INTO THE ORIFICE. HOST TISSUE WAS MODERATE AT THE STENT INFLOW AND HEAVY AT THE STENT OUTFLOW. X-RAY. ADDITIONAL MANUFACTURER NARRATIVE: THE EXPLANTED DEVICE WAS RETURNED TO EDWARDS FOR EVALUATION, WHICH CONFIRMED THE INITIAL REPORT OF CALCIFICATION AND PANNUS/HOST TISSUE OVERGROWTH CAUSING AORTIC VALVE STENOSIS. THERE IS NO CHANGE IN THE ORIGINAL CONCLUSION OF THIS CASE. NO FURTHER ACTIONS ARE POSSIBLE WITH THE AVAILABLE INFORMATION.

    Description of Event or Problem · 1

    IN THIS CASE, IT WAS REPORTED THAT THE VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF APPROXIMATELY 8 YEARS DUE TO PROSTHETIC AORTIC VALVE STENOSIS WITH CALCIFICATION. PER THE OP REPORT, ECHO CONFIRMED PROSTHETIC VALVE STENOSIS WITH 120 MM GRADIENT. DURING REMOVAL OF THE VALVE, THERE WAS NO EVIDENCE OF INFECTION. THERE WAS SIGNIFICANT PANNUS OVERGROWTH OF THE SEWING RING OUT ONTO THE PROSTHETIC LEAFLETS. THERE WAS MODERATE CALCIUM SEEN IN THE LEAFLETS AS WELL. THE DEVICE WAS REMOVED IN ITS ENTIRETY AND REPLACED WITH A NEW EDWARDS BIOPROSTHETIC VALVE. THE PATIENT WAS EASILY WEANED FROM CARDIOPULMONARY BYPASS WITH GOOD LV FUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236517 CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 3000 5A0003

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| R