BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS

    MDR report key: 3864601 · Received June 10, 2014

    Report

    Report Number
    2015691-2014-01337
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    May 12, 2014
    Report Date
    May 12, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED DEVICE HAS BEEN RETURNED TO MANUFACTURER BUT HAS NOT YET BEEN EVALUATED. RESULTS OF THE EVALUATION WILL BE REPORTED ONCE COMPLETED; ADDITIONAL INFORMATION WILL BE REPORTED WHEN RECEIVED. EDWARDS WILL CONTINUE TO MONITOR ALL EVENTS.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION SUMMARY: CUSTOMER REPORT OF CALCIFICATION WAS CONFIRMED THICKENED AND SWOLLEN TISSUE WAS OBSERVED ON ALL THREE LEAFLETS AT ALL THREE COMMISSURES. MODERATE CALCIFICATION WAS OBSERVED IN THE CUSP AREA OF LEAFLET 2, MODERATE TO HEAVY CALCIFICATION WAS OBSERVED IN THE CUSP AREA OF LEAFLET 3. FREE MARGINS OF LEAFLET 2 EXHIBITED MODERATE CALCIFICATION AND FREE MARGIN OF LEAFLET 3 EXHIBITED MODERATE TO HEAVY CALCIFICATION. HOST TISSUE WAS HEAVY ON THE TISSUE INFLOW AND ENCROACHED ONTO THE TISSUE. HOST TISSUE WAS MODERATE TO HEAVY ON THE TISSUE OUTFLOW AND ENCROACHED ONTO THE TISSUE. 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 APPROXIMATELY 3MM AND LEAFLETS 2 AND 3 AT COMMISSURE 3 BY APPROX 4MM, BOTH ON THE OUTFLOW ASPECT. CALCIFICATION AND HOST TISSUE RESTRICTED MOBILITY IN THE LEAFLETS AND LED TO STENOSIS. HEMATOMA WAS ALSO OBSERVED ON LEAFLET 2. CUSTOMER REPORT OF CALCIFICATION AND HOST TISSUE WAS CONFIRMED THROUGH DEVICE EVALUATION. 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. EDWARDS WILL CONTINUE TO REVIEW AND MONITOR ALL EVENTS. TRENDS ARE MONITORED ON A MONTHLY BASIS AND IF ACTION IS REQUIRED, APPROPRIATE INVESTIGATION WILL BE PERFORMED.

    Description of Event or Problem · 1

    EDWARDS LEARNED OF A BIOPROSTHETIC VALVE EXPLANTED DUE TO SEVERE AORTIC STENOSIS SECONDARY TO HEAVY CALCIFICATION AND HOST TISSUE OVERGROWTH AFTER AN IMPLANT DURATION OF NINE (9) YEARS SIX (6) MONTHS. PATIENT WAS IMPLANTED WITH ANOTHER BIOPROSTHETIC VALVE. NO ADVERSE EVENTS WERE REPORTED POST-OP.

    Description of Event or Problem · 1

    DEVICE WAS RETURNED AND EVALUATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341007 CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 3000TFX

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| R