BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEE H11

    MDR report key: 19524991 · Received June 12, 2024

    Report

    Report Number
    2015691-2024-04530
    Event Type
    Injury
    Date Received
    June 12, 2024
    Report Date
    August 1, 2024
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    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

    H11: CORRECTED DATA: CORRECTED SECTIONS B5, D1, D4 (MODEL NUMBER), G4 (PMA/510K NUMBER).

    Additional Manufacturer Narrative · 0

    H11: ADDITIONAL MANUFACTURER NARRATIVE: UPDATED SECTION H6 (DEVICE CODE, TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS). CALCIFIC DEGENERATION IS A COMMON CAUSE OF BIOPROSTHETIC HEART VALVE FAILURES. MANY FACTORS CONTRIBUTE TO THE ONSET AND PROPAGATION OF CALCIFICATION. THESE INCLUDE PATIENT FACTORS (AGE, DISEASE STATE, PHARMACOLOGICAL INTERVENTION, ETC.), MECHANICAL STRESS RELATED TO THE VALVE'S HEMODYNAMIC PERFORMANCE, AND GLUTARALDEHYDE FIXATION OF TISSUE. OF THESE, THE FIXATION PROCESS IS A RELATIVELY MINOR CONTRIBUTOR TO CALCIFICATION FOR EDWARDS' TISSUE VALVES DUE TO ANTI-CALCIFICATION TREATMENTS DURING MANUFACTURING. THOUGH NUMEROUS STUDIES HAVE BEEN CONDUCTED ON PREVENTIVE CALCIFICATION STRATEGIES IN BIOPROSTHETIC HEART VALVES, THE CAUSES OF CALCIFICATION ARE NOT FULLY UNDERSTOOD AND THERE ARE STILL NO MECHANISMS OR MEDICAL THERAPIES WHICH FULLY PREVENT BIOPROSTHESES FROM CALCIFYING. PANNUS OVERGROWTH, OR HOST TISSUE, IS CONSIDERED 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." 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. CALCIFICATION IS MOST COMMONLY RELATED TO PATIENT FACTORS AND IS NOT USUALLY AN INDICATION OF A DEVICE MALFUNCTION. HOST FIBROUS (PANNUS) TISSUE GROWTH IS NOT A MALFUNCTION OF THE DEVICE RELATED TO A MANUFACTURING DEFICIENCY. THE ROOT CAUSE OF THIS EVENT CANNOT BE CONCLUSIVELY DETERMINED WITH THE AVAILABLE INFORMATION. THE EXPLANTED DEVICE IS NOT AVAILABLE FOR EVALUATION. HOWEVER, THE EVENT OBSERVED IN THIS CASE WAS LIKELY DUE TO A PROGRESSION OF THE PATIENT'S UNDERLYING VALVULAR DISEASE PATHOLOGY COMBINED WITH THE PATIENT'S OTHER UNDERLYING RISK FACTORS WITH STRUCTURAL VALVE DETERIORATION AND NONSTRUCTURAL DYSFUNCTION. 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

    H11: ADDITIONAL MANUFACTURER NARRATIVE: THIS MODEL IS NOT SOLD OR MARKETED IN THE U.S. HOWEVER, IT IS SIMILAR TO DEVICE: MODEL #2800; BRAND NAME: CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS; PMA # P860057. 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.

    Description of Event or Problem · 0

    THROUGH REVIEW OF MEDICAL ARTICLE 'THE EARLY AND MID-TERM HEMODYNAMIC ADVANTAGES OF THE EDWARDS INTUITY ELITE VALVE SYSTEM', THE FOLLOWING EVENT WAS IDENTIFIED AS PERTAINING TO AN EDWARDS DEVICE: STRUCTURAL VALVE DETERIORATION FOR 25 CASES AFTER IMPLANTATION. PER THIS ARTICLE, 25 UNKNOWN CARPENTIER-EDWARDS PERICARDIAL VALVES WERE EXPLANTED AT UNKNOWN DATES DUE TO CALCIFICATION AND PANNUS. THE EARLY AND MID-TERM HEMODYNAMIC ADVANTAGES OF THE EDWARDS INTUITY ELITE VALVE SYSTEM (EIE) COMPARED WITH CONVENTIONAL BIOPROSTHETIC VALVES. WE ASSESSED 196 PATIENTS WHO UNDERWENT AORTIC VALVE REPLACEMENT AT OUR HOSPITAL BETWEEN 2019 AND APRIL 2023 (84 PATIENTS FOR EIE, 112 PATIENTS FOR MAGNA-EASE OR INSPIRIS). WE ALSO ASSESSED 25 PATIENTS WHO EXPLANTED THE CARPENTIER-EDWARDS PERICARDIAL VALVE DUE TO STRUCTURAL VALVE DETERIORATION (SVD). AS AN EARLY-TERM RESULT, HEMODYNAMICS IS BETTER WITH EIE EXCEPT FOR 23MM SIZE, BUT THERE IS NO SIGNIFICANT DIFFERENCE CONFIRMED. AS A MID-TERM RESULT, MEAN PRESSURE GRADIENT OF EIE WAS LOW FOR ALL VALVE SIZES AND IT WAS SIGNIFICANT WITH LESS THAN 21 MM SIZE. WE REVIEWED 25 EXPLANTED VALVES DUE TO SVD TO CONFIRM PANNUS INVOLVEMENT. THE CAUSE OF SVD WAS DUE TO RESTRICTED OPENING MOTION OF THE LEAFLETS CAUSED BY CALCIFICATION, AND REGURGITATION DUE TO DECREASED VALVE AREA CAUSED BY PANNUS FORMATION AND LEAFLET TORN AT STENT POST AREA. MID-TERM RESULTS SHOWED THAT EIE HAD BETTER HEMODYNAMICS COMPARED WITH MAGNA AND INSPIRS VALVES, ESPECIALLY IN SMALLER SIZE VALVES. EIE MAY BE THE FIRST CHOICE FOR THE AORTIC VALVE REPLACEMENT WITH A NARROW ANNULUS IF HEMODYNAMICS IS PRIORITIZED WHILE UNDERSTANDING THE DISADVANTAGES (AV-BLOCK, PVL) OF EIE.

    Description of Event or Problem · 0

    THROUGH REVIEW OF MEDICAL ARTICLE 'THE EARLY AND MID-TERM HEMODYNAMIC ADVANTAGES OF THE EDWARDS INTUITY ELITE VALVE SYSTEM', THE FOLLOWING EVENT WAS IDENTIFIED AS PERTAINING TO AN EDWARDS DEVICE: STRUCTURAL VALVE DETERIORATION FOR 25 CASES AFTER IMPLANTATION. THE EARLY AND MID-TERM HEMODYNAMIC ADVANTAGES OF THE EDWARDS INTUITY ELITE VALVE SYSTEM (EIE) COMPARED WITH CONVENTIONAL BIOPROSTHETIC VALVES. 196 PATIENTS WERE ASSESSED WHO UNDERWENT AORTIC VALVE REPLACEMENT BETWEEN 2019 AND APRIL 2023 (84 PATIENTS FOR EIE, 112 PATIENTS FOR MAGNA-EASE OR INSPIRIS). 25 PATIENTS WERE ASSESSED WHO HAD THE CARPENTIER-EDWARDS PERICARDIAL VALVE EXPLANTED DUE TO STRUCTURAL VALVE DETERIORATION (SVD). AS AN EARLY-TERM RESULT, HEMODYNAMICS IS BETTER WITH EIE EXCEPT FOR 23MM SIZE, BUT THERE IS NO SIGNIFICANT DIFFERENCE CONFIRMED. AS A MID-TERM RESULT, MEAN PRESSURE GRADIENT OF EIE WAS LOW FOR ALL VALVE SIZES AND IT WAS SIGNIFICANT WITH LESS THAN 21 MM SIZE. 25 EXPLANTED VALVES DUE TO SVD TO CONFIRM PANNUS INVOLVEMENT. THE CAUSE OF SVD WAS DUE TO RESTRICTED OPENING MOTION OF THE LEAFLETS CAUSED BY CALCIFICATION, AND REGURGITATION DUE TO DECREASED VALVE AREA CAUSED BY PANNUS FORMATION AND LEAFLET TORN AT STENT POST AREA. MID-TERM RESULTS SHOWED THAT EIE HAD BETTER HEMODYNAMICS COMPARED WITH MAGNA AND INSPIRS VALVES, ESPECIALLY IN SMALLER SIZE VALVES. EIE MAY BE THE FIRST CHOICE FOR THE AORTIC VALVE REPLACEMENT WITH A NARROW ANNULUS IF HEMODYNAMICS IS PRIORITIZED WHILE UNDERSTANDING THE DISADVANTAGES (AV-BLOCK, PVL) OF EIE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182764 SEE H11 REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 2900

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| H| L