BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS

    MDR report key: 2884408 · Received December 22, 2012

    Report

    Report Number
    2015691-2012-18947
    Event Type
    Injury
    Date Received
    December 22, 2012
    Date of Event
    November 26, 2012
    Report Date
    November 26, 2012
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: AS RECEIVED, HEAVY HOST TISSUE OVERGROWTH ENCROACHED ONTO THE TISSUE AT THE INFLOW ASPECT AND INTO THE ORIFICE AT THE GREATEST POINT BY APPROXIMATELY 11MM. HEAVY HOST TISSUE OVERGROWTH ENCROACHED ONTO THE TISSUE AT THE OUTFLOW ASPECT AND INTO THE ORIFICE AT THE GREATEST POINT BY APPROXIMATELY 7MM. HOST TISSUE WAS MODERATE TO HEAVY AT THE STENT OUTFLOW AND HEAVY AT THE STENT INFLOW. HOST TISSUE FUSED LEAFLETS 1 AND 2 AT COMMISSURE 2 BY 10MM AND LEAFLETS 2 AND 3 AT COMMISSURE 3 BY 6 MM AT THE INFLOW ASPECT. HOST TISSUE FUSED LEAFLETS 1 AND 2 AT COMMISSURE 2 BY 5MM AND LEAFLETS 2 AND 3 AT COMMISSURE 3 BY 5 MM AT THE OUTFLOW ASPECT. IT ALSO RESTRICTED MOBILITY IN THE LEAFLETS WHICH MAY LEAD TO STENOSIS. MINIMAL CALCIFICATION WAS OBSERVED IN THE CUSP AREA OF LEAFLET 2. NO INCONSISTENCIES DETECTED IN THE X-RAY AS THE WIREFORM IS INTACT. METHOD: X-RAY. THE DHR REVIEW WAS COMPLETED. THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE. EVALUATION CONFIRMS CUSTOMER REPORT OF STENOSIS. STENOSIS IS MOST LIKELY THE RESULT OF CALCIFICATION AND/OR HOST TISSUE OVERGROWTH RESTRICTING MOVEMENT OF THE LEAFLETS OF THE BIOPROSTHETIC DEVICE. 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. IN THIS CASE, MINIMAL CALCIFICATION WAS PRESENT IN THE LEAFLETS AND WOULD NOT BE THE ROOT CAUSE FOR EXPLANT OF THIS DEVICE.

    Description of Event or Problem · 1

    REPORTEDLY THE DEVICE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 76.40 MONTHS (6 YEARS, 4 MONTHS) DUE TO SEVERE MITRAL INSUFFICIENCY. CUSTOMER REPORTED: PATIENT PRESENTED WITH SYMPTOMS OF WORSENING DYSPNEA, SEVERE MITRAL PROSTHETIC VALVE STENOSIS/INSUFFICIENCY. CONDITION OF DEVICE AT EXPLANT: INTACT WITH SCLEROTIC LEAFLETS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 6900P 06C057

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| R