BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS

    MDR report key: 4102966 · Received September 19, 2014

    Report

    Report Number
    2015691-2014-02189
    Event Type
    Injury
    Date Received
    September 19, 2014
    Date of Event
    August 22, 2014
    Report Date
    August 22, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL MANUFACTURER NARRATIVE: THE DEVICE HISTORY RECORD WAS REVIEWED AND SHOWED THAT THIS DEVICE MET ALL MANUFACTURING SPECIFICATIONS FOR PRODUCT RELEASED FOR DISTRIBUTION. NO ISSUES WERE IDENTIFIED THAT WOULD HAVE IMPACTED THIS EVENT.

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE EXPLANTED DEVICE WAS RETURNED AND EVALUATED; AS RECEIVED, LEAFLET 1 HAD A CUT AREA OF APPROX 13MM X 6MM. CUT SECTIONS WAS NOT RETURNED WITH THE VALVE. MINIMAL TO MODERATE CALCIFICATION WAS OBSERVED IN THE REMAINING CUSP AREA OF LEAFLET 1, MODERATE CALCIFICATION WAS OBSERVED IN THE CUSP AREAS OF LEAFLETS 2 AND 3. FREE MARGIN OF LEAFLET 1 EXHIBITED MODERATE CALCIFICATION. MINIMAL HOST TISSUE OVERGROWTH ENCROACHED ONTO THE TISSUE AT THE INFLOW ASPECT AND INTO THE ORIFICE AT THE GREATEST POINT BY APPROXIMATELY 4MM. MODERATE TO HEAVY HOST TISSUE OVERGROWTH ENCROACHED ONTO THE TISSUE AT THE OUTFLOW ASPECT AND INTO THE ORIFICE AT THE GREATEST POINT BY APPROXIMATELY 11MM. HOST TISSUE WAS HEAVY AT THE STENT INFLOW AND MODERATE TO HEAVY AT THE STENT OUTFLOW. HOST TISSUE FUSED LEAFLETS 1 AND 3 AT COMMISSURE 1 BY APPROX 3MM ON THE OUTFLOW ASPECT. EDWARDS GROSS ANALYSIS SUGGESTS THAT CALCIFICATION AND HOST TISSUE OVERGROWTH ARE THE PRIMARY CAUSES OF THE REPORTED STENOSIS. BIOPROSTHETIC LEAFLET CALCIFICATION AND HOST TISSUE OVERGROWTH ARE TWO COMMON CHRONIC FAILURE MODES IN BIOPROSTHETIC HEART VALVES. THEIR OCCURRENCE IS HIGHLY VARIABLE AMONG PATIENTS. IT IS GENERALLY BELIEVED THAT PATIENT BIOLOGICAL FACTORS AND/OR PREEXISTING MEDICAL CONDITIONS AND COMORBIDITIES PLAY MAJOR ROLES IN THE DEVELOPMENT OF BIOPROSTHETIC TISSUE CALCIFICATION AND/OR HOST FIBROTIC TISSUE OVERGROWTH. HOWEVER, THE UNDERLYING MECHANISMS ARE NOT COMPLETELY UNDERSTOOD. IN THIS CASE, THE PATIENT WAS NOTED TO BE A HEAVY DRINKER. NO FURTHER ACTION IS REQUIRED AT THIS TIME, EDWARDS WILL CONTINUE TO REVIEW AND MONITOR ALL EVENTS.

    Description of Event or Problem · 1

    EDWARDS RECEIVED INFORMATION THAT A MITRAL BIOPROSTHETIC VALVE MODEL WAS EXPLANTED AFTER AN IMPLANT DURATION OF APPROXIMATELY SEVEN (7) YEARS DUE TO MITRAL STENOSIS. IT WAS NOTED THAT THE PATIENT IS A HEAVY DRINKER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    583890 CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 6900P

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| L| R