BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS

    MDR report key: 3910930 · Received July 2, 2014

    Report

    Report Number
    2015691-2014-01510
    Event Type
    Injury
    Date Received
    July 2, 2014
    Date of Event
    May 19, 2014
    Report Date
    June 5, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED DEVICE HAS BEEN RETURNED TO MANUFACTURER BUT EVALUATION HAS NOT YET BEGUN. EVALUATION RESULTS WILL BE REPORTED WHEN COMPLETED.

    Additional Manufacturer Narrative · 1

    OTHER=X-RAYS. DEVICE EVALUATION SUMMARY - AS RECEIVED, LEAFLET 2 HAD A CUT AREA APPROX 8MMX5MM. LEAFLET 3 HAD A CUT AREA APPROX 8MMX5MM. CUT SECTIONS WERE NOT RETURNED WITH THE DEVICE. MINIMAL TO MODERATE CALCIFICATION WAS OBSERVED IN THE CUSP AREA OF LEAFLET 1 AND THE REMAINING SECTIONS OF LEAFLETS 2 AND 3. THE FREE MARGINS OF LEAFLET 1 AND 3 EXHIBITED MINIMAL CALCIFICATION. CALCIFICATION RESTRICTED MOBILITY IN THE LEAFLETS AND LED TO STENOSIS. LEAFLET 1 HAD A TEAR AT COMMISSURE 1, TEAR MEASURED APPROX 3MM IN LENGTH. LEAFLET 3 ALSO HAD A TEAR AT COMMISSURE 1 APPROX 3MM IN LENGTH. LEAFLET 2 HAD A TEAR AT COMMISSURE 2, TEAR MEASURED APPROX 4MM IN LENGTH. CALCIFICATION WAS OBSERVED NEAR THE REGIONS OF THE TEARS. MINIMAL TO MODERATE HOST TISSUE OVERGROWTH ENCROACHED ONTO THE TISSUE AT THE INFLOW ASPECT AND INTO THE ORIFICE AT THE GREATEST POINT BY APPROXIMATELY 3MM. MINIMAL HOST TISSUE OVERGROWTH ENCROACHED ONTO THE TISSUE AT THE OUTFLOW ASPECT AND INTO THE ORIFICE. HOST TISSUE WAS MODERATE AT THE STENT INFLOW AND MINIMAL TO MODERATE AT THE STENT OUTFLOW. HOST TISSUE FUSED LEAFLETS 1 AND 3 AT COMMISSURE 1 ON THE OUTFLOW ASPECT BY APPROX 3MM. THROMBI WAS ALSO OBSERVED ON ALL THREE LEAFLETS. ADDITIONAL MANUFACTURER NARRATIVE - DEVICE EVALUATION INDICATES TEARS CAUSED BY CALCIFIC DEGENERATION AND HOST TISSUE OVERGROWTH AS THE PRIMARY CAUSE LEADING TO THE REPORTED STENOSIS AND REGURGITATION. 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. EDWARDS WILL CONTINUE TO REVIEW AND MONITOR ALL EVENTS. NO FURTHER ACTION IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    EDWARDS RECEIVED INFORMATION THAT A 21MM BIOPROSTHETIC AORTIC VALVE, IMPLANTED APPROXIMATELY TEN (10) YEARS AND THREE (3) MONTHS, WAS EXPLANTED DUE TO TWO OF THREE FUSED LEAFLETS THAT WERE COMPLETELY IMMOBILE SECONDARY TO CALCIFICATION AND LEADING TO STENOSIS AND REGURGITATION. THE EXPLANTED DEVICE WAS REPLACED WITH ANOTHER BIOPROSTHETIC VALVE. THE PATIENT IS REPORTED IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    386715 CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 2800

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R