BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS

    MDR report key: 1871725 · Received October 15, 2010

    Report

    Report Number
    2015691-2010-14205
    Event Type
    Injury
    Date Received
    October 15, 2010
    Date of Event
    September 16, 2010
    Report Date
    September 16, 2010
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: HEAVY CALCIFICATION IS DETECTED IN THE CUSP AREA OF ALL THREE LEAFLETS AND THE FREE MARGIN OF LEAFLET 1. CALCIFICATION RESTRICTED MOBILITY IN THE LEAFLETS AND LED TO STENOSIS. MODERATE HOST TISSUE OVERGROWTH ENCROACHED ONTO THE TISSUE OUTFLOW AT THE GREATEST DISTANCE OF APPROXIMATELY 4-5MM. MINIMAL HOST TISSUE OVERGROWTH ENCROACHED ONTO THE TISSUE INFLOW AND INTO THE ORIFICE BY 3-4MM. HOST TISSUE IS MODERATE AT THE STENT INFLOW AND MINIMAL AT THE STENT OUTFLOW. THE X-RAY DEMONSTRATES CALCIFICATION. (MODEL# 6900P, SIZE: 29MM - MEASURED WITH CALIPER MET ID# IR005852). METHOD: X-RAY. ADDITIONAL MANUFACTURER NARRATIVE: CONCLUSION: IT HAS BEEN DETERMINED THROUGH EVALUATION THAT THE DEVICE WAS AFFECTED BY CALCIFICATION (PRIMARY) AND PANNUS GROWTH (SECONDARY). THIS CONFIRMS THE REASON FOR EXPLANT, AS REPORTED BY THE HEALTH CARE PROVIDER. 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. SINCE NO PATIENT HISTORY WAS PROVIDED, THE ROOT CAUSE FOR CALCIFICATION CANNOT BE DETERMINED AT THIS TIME. 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.

    Additional Manufacturer Narrative · 1

    THE DEVICE MODEL AND SERIAL NUMBER WAS NOT REPORTED; THEREFORE, THE DHR CAN NOT BE STARTED. REQUESTED SALES REP GET THIS INFORMATION FROM THE HEALTH CARE PROVIDER. THE DEVICE IS BEING RETURNED FOR EVALUATION AND A CUSTOMER LETTER HAS BEEN REQUESTED. SURGEON HAS GIVEN PERMISSION TO DISASSEMBLE THE DEVICE FOR SERIAL NUMBER. THIS EVENT WAS DETERMINED TO BE REPORTABLE PER EDWARDS LIFESCIENCES PROCEDURES. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    REPORTEDLY, THE DEVICE WAS EXPLANTED AFTER A DURATION OF 75.60 MONTHS DUE TO CALCIFICATION. THE CUSTOMER REPORT STATES ONLY "CALCIFICATION OF MITRAL VALVE". NO DEVICE INFORMATION HAS BEEN PROVIDED. NO PATIENT HISTORY PROVIDED.

    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

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| R