BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL PERICARDIAL BIOPROSTHESIS

    MDR report key: 19812712 · Received July 23, 2024

    Report

    Report Number
    2015691-2024-05593
    Event Type
    Injury
    Date Received
    July 23, 2024
    Date of Event
    January 1, 2024
    Report Date
    August 27, 2024
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H11: ADDITIONAL MANUFACTURER NARRATIVE: UPDATED SECTIONS: B4, G3, G6, H2, H4, H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, AND INVESTIGATION CONCLUSIONS). THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED, AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS PRIOR TO RELEASE FOR DISTRIBUTION. THERE WERE NO ISSUES IDENTIFIED THAT WOULD HAVE IMPACTED THIS EVENT. ENGINEERING EVALUATION SUMMARY: SVD CALCIFICATION: PER DOC-0221939, "SVD IS A LOGICAL AND EXPECTED CONSEQUENCE OF THE CHEMICAL, MECHANICAL, AND IMMUNOLOGICAL PROCESSES ASSOCIATED WITH BHV IMPLANTATION. THE COMMON ENDPOINT OF ALL THESE FACTORS IS CALCIFICATION AND DEGRADATION. SVD IS AN ACQUIRED CONDITION, INTRINSIC TO BIOPROSTHETIC VALVES, CHARACTERIZED BY DETERIORATION OF THE LEAFLETS OR SUPPORTING STRUCTURES, LEADING TO THICKENING, CALCIFICATION, TEARING, OR DISRUPTION OF THE PROSTHETIC VALVE MATERIALS. THESE CHANGES RESULT IN VALVULAR DYSFUNCTION MANIFESTING AS STENOSIS AND/OR REGURGITATION WITH A CONSEQUENT DROP IN HEMODYNAMIC EFFICACY OF THE VALVE. DESPITE THE ADVANCEMENTS IN THE HEART VALVE INDUSTRY, SVD COMMONLY BEGINS 7- 8 YEARS AFTER IMPLANTATION, WITH A CONSIDERABLY INCREASED RATE IN PATIENTS WITH PERTINENT COMORBIDITIES AND/OR AN IMPLANT DURATION OF GREATER THAN 10 YEARS. PRIOR INVESTIGATIONS AND EXTENSIVE LITERATURE REVIEWHAVE SHOWN THAT SVD IS PREDOMINANTLY RELATED TO PATIENT FACTORS AND IMPLANT DURATION RATHER THAN TO MANUFACTURING ISSUES. EVENTS RELATED TO DEVICE DESIGN, MANUFACTURING, OR USE ERROR TEND TO MANIFEST AT AN EARLIER IMPLANT DURATION." BASED ON THE INFORMATION AVAILABLE, THE MOST LIKELY ROOT CAUSE IS PATIENT FACTORS, INCLUDING HYPERLIPIDEMIA AND CORONARY ARTERY DISEASE. NSVD HOST TISSUE/PANNUS: PANNUS IS A NON-IMMUNE INFLAMMATORY REACTION OF THE BODY TO THE IMPLANTED PROSTHESIS, CHARACTERIZED BY PROLIFERATION OF FIBROELASTIC TISSUE AND COLLAGEN, WITH A STARTING POINT IN THE SUTURE AREA AND SUBACUTE OR CHRONIC CENTRIPETAL EVOLUTION. PANNUS CAN HAVE BOTH BENEFICIAL AND HARMFUL EFFECTS DEPENDING ON THE AMOUNT OF GROWTH AND LOCATION. A SMALL AMOUNT OF HOST TISSUE GROWTH OVER THE SUTURE LINE IS EXPECTED AND IS NEEDED TO FORM A NON-THROMBOGENIC SURFACE AND COMPLETE THE HEALING PROCESS AFTER DEVICE IMPLANTATION. IN CONTRAST, AN EXCESSIVE AMOUNT OF PANNUS GROWTH CAN CAUSE NONSTRUCTURAL DYSFUNCTION THAT MAY REQUIRE INTERVENTION. HOST TISSUE GROWTH CAN EXTEND ONTO THE CUSP SURFACES LEADING TO THICKENING OF THE CUSPS, CUSP RETRACTION OR CURLING, LEAFLET IMMOBILITY, AND/OR ABNORMAL COAPTATION, POTENTIALLY RESULTING IN VALVULAR REGURGITATION, ELEVATED GRADIENTS, AND/OR STENOSIS. PANNUS/HOST TISSUE IS MOST LIKELY DUE TO PATIENT FACTORS AND IS UNLIKELY TO BE RELATED TO A MANUFACTURING NON-CONFORMANCE. THE MOST LIKELY ROOT CAUSE IS PATIENT FACTORS. ALL PERTINENT INFORMATION AVAILABLE TO EDWARDS LIFESCIENCES HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    THE SUBJECT DEVICE IS NOT AVAILABLE FOR EVALUATION, AS DEVICE RETURN REQUESTS ARE STILL BEING SENT OUT PER INVESTIGATION. 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

    H11: ADDITIONAL MANUFACTURER NARRATIVE: THE SUBJECT DEVICE IS NOT AVAILABLE FOR EVALUATION, AS DEVICE RETURN REQUESTS ARE STILL BEING SENT OUT PER INVESTIGATION. 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

    IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY AND INVESTIGATION THAT A PATIENT WITH A 27MM 7000TFX MITRAL VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF APPROXIMATELY 8 YEARS DUE TO CALCIFICATION AND STENOSIS. PATIENT PRESENTED WITH HEART FAILURE. THE EXPLANTED VALVE WAS REPLACED WITH A NON-EDWARDS DEVICE. THE PATIENT WAS DISCHARGED POD #8. EDWARDS LIFESCIENCES MAINTAINS AN IMPLANT PATIENT REGISTRY. THIS REGISTRY IS A PATIENT TRACKING MECHANISM FOR SERIALIZED EDWARDS IMPLANTABLE DEVICES (BIOPROSTHETIC HEART VALVES AND ANNULOPLASTY RINGS), RATHER THAN A TRUE POST-MARKET SURVEILLANCE REGISTRY. THROUGH THE REGISTRY, EDWARDS IS NOTIFIED WHEN THESE DEVICES ARE IMPLANTED. IN ADDITION, PATIENT AND/OR DEVICE STATUS MAY BE REPORTED TO THE REGISTRY VIA THE IMPLANTATION DATA CARDS. THE INFORMATION IS RECEIVED FROM VARIOUS SOURCES (E.G. SURGEON, HOSPITAL, AND PATIENT FAMILY MEMBERS) AND IS NOT RECEIVED IN THE FORM OF A CONVENTIONAL "CUSTOMER COMPLAINT". THE INFORMATION REPORTED MAY OR MAY NOT BE RELATED TO THE EDWARDS DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349252 CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 7000TFX NA

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Female Life Threatening| R| H