BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL PERICARDIAL BIOPROSTHESIS

    MDR report key: 3870771 · Received June 12, 2014

    Report

    Report Number
    2015691-2014-01376
    Event Type
    Injury
    Date Received
    June 12, 2014
    Date of Event
    April 11, 2014
    Report Date
    April 11, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S029
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: MODERATE HOST TISSUE OVERGROWTH ENCROACHED ONTO THE TISSUE AT THE INFLOW ASPECT AND INTO THE ORIFICE AT THE GREATEST POINT BY APPROXIMATELY 9MM. HEAVY HOST TISSUE OVERGROWTH ENCROACHED ONTO THE TISSUE AT THE OUTFLOW ASPECT AND INTO THE ORIFICE. HOST TISSUE WAS HEAVY AT BOTH THE STENT INFLOW AND STENT OUTFLOW. HOST TISSUE FUSED LEAFLETS 1 AND 3 AT COMMISSURE 1 BY APPROX 4MM, LEAFLETS 1 AND 2 AT COMMISSURE 2 BY APPROX 4MM AND LEAFLETS 2 AND 3 AT COMMISSURE 3 BY APPROX 5MM, ALL ON THE OUTFLOW ASPECT. HOST TISSUE FOLDED THE FREE MARGIN OF LEAFLET 3 ONTO ITSELF BY APPROX 2MM, NEAR COMMISSURE 1. WHAT APPEARED TO BE CHORDAE/SUBVALVULAR TISSUE WAS ALSO OBSERVED AROUND THE CIRCUMFERENCE OF THE SEWING RING. MINIMAL CALCIFICATION WAS OBSERVED IN THE CUSP AREAS OF LEAFLETS 1 AND 2. THE FREE MARGIN OF LEAFLET 1 EXHIBITED MODERATE CALCIFICATION, FREE MARGIN OF LEAFLET 2 EXHIBITED MINIMAL TO MODERATE CALCIFICATION AND FREE MARGIN OF LEAFLET 3 EXHIBITED MINIMAL CALCIFICATION. HOST TISSUE AND CALCIFICATION RESTRICTED MOBILITY IN THE LEAFLETS AND LED TO STENOSIS. THE X-RAY DEMONSTRATED COMMISSURE 1 WIREFORM DISTORTED. THESE DAMAGES ARE MOST LIKELY DUE TO IMPLANT OR EXPLANT. DEVICE EVALUATION DEMONSTRATED THAT HOST TISSUE AND CALCIFICATION LED TO STENOSIS OF THE VALVE. BIOPROSTHETIC LEAFLET CALCIFICATION AND HOST TISSUE OVERGROWTH ARE TWO COMMON 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. THE PATIENT IS NOTED TO RELATIVELY YOUNG - (B)(6), THIS MAY HAVE PLAYED A ROLE IN THE EXPLANT OF THIS DEVICE. THE DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND CONFIRMS THAT THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS. 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.

    Additional Manufacturer Narrative · 1

    (B)(4) - ELEVATED GRADIENT. ADDITIONAL MANUFACTURER NARRATIVE - THE REPORTED DEVICE HAS NOT YET BEEN EXPLANTED THEREFORE HAS NOT BEEN RETURNED TO MANUFACTURER. WITHOUT RECEIPT OF THE EXPLANTED DEVICE THE REPORTED CLINICAL OBSERVATION CANNOT BE CONFIRMED AND A ROOT CAUSE CANNOT BE DETERMINED OR EVALUATED. EDWARDS WILL CONTINUE TO MONITOR ALL EVENTS. HOWEVER, IT IS POSSIBLE THAT THIS PATIENT (B)(6) AND MEDICAL HISTORY (NOT PROVIDED) MAY HAVE CONTRIBUTED TO THIS EVENT. ADDITIONAL INFORMATION WILL REPORTED IF RECEIVED.

    Description of Event or Problem · 1

    EDWARDS RECEIVED INFORMATION THAT AN EDWARDS MITRAL BIOPROSTHETIC VALVE IS NOW FAILING IN A (B)(6) FEMALE PATIENT DUE TO STRUCTURAL DETERIORATION AFTER AN IMPLANT DURATION OF APPROXIMATELY FIVE (5) YEARS. THE PATIENT WAS (B)(6) AT IMPLANT OF THE SUBJECT VALVE. FOLLOW UP WITH PATIENT INDICATES SHE CURRENTLY PRESENTS WITH FATIGUE, DYSPNEA AND CHEST PAIN. TEE PERFORMED INDICATES AN INCREASE IN TRANSVALVULAR GRADIENTS (35 MMHG PEAK, 16.7 MMHG MEAN) AND VELOCITY (2.9 M/SEC). PATIENTS HCP INDICATES SHE IS NOW A CANDIDATE FOR RE-DO MVR. INTERVENTION HAS NOT YET TAKEN PLACE.

    Description of Event or Problem · 1

    UPDATE WAS RECEIVED INDICATING THAT PATIENT UNDERWENT REPLACEMENT OF THE SUBJECT VALVE. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THE EXPLANT. EXPLANTED DEVICE HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347354 CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 7000TFX

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Hospitalization| L| R