BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERICARDIAL BIOPROSTHESIS

    MDR report key: 14754763 · Received June 21, 2022

    Report

    Report Number
    2015691-2022-06287
    Event Type
    Injury
    Date Received
    June 21, 2022
    Date of Event
    March 19, 2021
    Report Date
    August 26, 2022
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    UDI-DI
    07612989036036
    PMA / PMN Number
    P860057
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS STILL IN PROGRESS; THEREFORE, A CONCLUSION HAS YET TO BE ESTABLISHED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY UPON INVESTIGATION COMPLETION. EDWARDS WILL CONTINUE TO REVIEW AND MONITOR ALL REPORTED EVENTS. TRENDS ARE MONITORED ON A MONTHLY BASIS AND IF ACTION IS REQUIRED, APPROPRIATE INVESTIGATION WILL BE PERFORMED.

    Additional Manufacturer Narrative · 0

    H10: ADDITIONAL MANUFACTURER NARRATIVE: UPDATED: B4, D4, G3, G6, H2, H4, H6. THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS PRIOR TO RELEASE FOR DISTRIBUTION. PANNUS OVERGROWTH, OR HOST TISSUE, IS CONSIDERED TO BE A FORM OF NON-STRUCTURAL VALVE DYSFUNCTION. THE GROWTH OF HOST TISSUE ON THE SEWING RING IS EXPECTED AND IS A NATURAL PART OF THE HEALING REACTION TO PROSTHESIS IMPLANTATION. PANNUS CAN HAVE BOTH BENEFICIAL AND HARMFUL EFFECTS DEPENDING ON THE AMOUNT OF GROWTH. A SMALL AMOUNT OF HOST TISSUE GROWTH OVER THE SUTURE LINE IS NEEDED TO FORM A NON-THROMBOGENIC SURFACE AND COMPLETE THE HEALING PROCESS AFTER VALVE IMPLANTATION. IN CONTRAST, IF THERE IS AN EXCESSIVE AMOUNT OF PANNUS GROWTH, IT CAN EXTEND ONTO THE CUSP SURFACES LEADING TO THICKENING OF THE CUSPS, LEAFLET IMMOBILITY, ELEVATED GRADIENTS, AND STENOSIS. HOST TISSUE GROWTH CAN ALSO CONTRIBUTE TO CUSP RETRACTION OR CURLING RESULTING IN VALVULAR REGURGITATION. HOST FIBROUS (PANNUS) TISSUE GROWTH IS NOT A MALFUNCTION OF THE DEVICE. THE MOST LIKELY CAUSE IS PATIENT FACTORS.

    Additional Manufacturer Narrative · 0

    CUSTOMER REPORTS OF STENOSIS AND PANNUS WERE CONFIRMED. REPORT OF REGURGITATION WAS UNABLE TO BE CONFIRMED THROUGH VISUAL OBSERVATIONS. X-RAY DEMONSTRATED WIREFORM INTACT. MODERATE HOST TISSUE OVERGROWTH ENCROACHED ONTO THE TISSUE AND INTO THE ORIFICE AT THE GREATEST DISTANCE OF APPROXIMATELY 9MM ON LEAFLET 1 AT THE INFLOW ASPECT AND 10MM ON LEAFLET 1 AT THE OUTFLOW ASPECT. THE FREE MARGIN OF LEAFLETS 1 AND 2 WERE ROLLED TOWARDS THE OUTFLOW ASPECT FROM HOST TISSUE OVERGROWTH. HOST TISSUE OVERGROWTH ON THE STENT CIRCUMFERENCE WAS MINIMAL AT BOTH THE INFLOW AND OUTFLOW ASPECTS. HOST TISSUE OVERGROWTH RESTRICTED LEAFLET MOBILITY AND LED TO STENOSIS. WIREFORM WAS EXPOSED AROUND LEAFLET 1 ON THE INFLOW ASPECT. SEWING CLOTH HAD MULTIPLE CUTS AROUND THE SEWING RING.

    Description of Event or Problem · 0

    EDWARDS RECEIVED INFORMATION THAT A 29MM 7300TFXJ MITRAL PERICARDIAL VALVE, IMPLANTED APPROXIMATELY TWO (2) YEARS AND SIX(6) MONTHS, WAS EXPLANTED DUE TO MITRAL STENOSIS AND REGURGITATION SECONDARY TO PANNUS OVERGROWTH (2022-10009-01). THE PATIENT PRESENTED WITH SYMPTOMS OF HEART FAILURE THAT HAD BEEN OBSERVED APPROXIMATELY ONE (1) YEAR AND FOUR (4) MONTHS AFTER THE VALVE IMPLANT. THIS 29MM 7300TFXJ VALVE WAS INITIALLY REPLACED WITH A 25MM 11400M VALVE, HOWEVER, A PARAVALVULAR LEAK (PVL) WAS OBSERVED INTRAOPERATIVELY DUE TO OPERATIONAL FACTORS (2022-10009-02). THE SURGEON ATTEMPTED TO FIX IT BUT COULD NOT STOP PVL. THIS 25MM 11400M VALVE WAS EXPLANTED AND REPLACED WITH THE ANOTHER SAME SIZE AND MODEL 25MM 11400M VALVE WHILE THE PATIENT WAS ON BYPASS WITH NO ADVERSE PATIENT EVENTS REPORTED. THE SURGEON COMMENTED THAT PANNUS OVERGROWTH TO 29MM 7300TFXJ VALVE WAS FASTER THAN EXPECTED. THE DEVICE WILL BE RETURNED FOR EVALUATION. THE PATIENT STATUS WAS REPORTED AS "RECOVERING".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1894947 CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART-VALVE DYE EDWARDS LIFESCIENCES 7300TFXJ29 07612989036036

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male Required Intervention| H| L