BEUDAMED
    FDA Adverse Event Death Summary report: N

    SEEH11

    MDR report key: 23941849 · Received January 2, 2026

    Report

    Report Number
    2015691-2026-10147
    Event Type
    Death
    Date Received
    January 2, 2026
    Date of Event
    November 20, 2025
    Report Date
    February 6, 2026
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    SEEH11
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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/S001. THE DEVICE WAS NOT RETURNED FOR EVALUATION, AS THE DEVICE WAS SENT TO THE SITE'S PATHOLOGY DEPARTMENT. 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

    INFORMATION ADDED/UPDATED TO SECTION H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS AND INVESTIGATIONS CONCLUSIONS). H11: ADDITIONAL MANUFACTURER NARRATIVE: THE DEVICE WAS NOT RETURNED FOR EVALUATION. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED, AND NO RELEVANT NON-CONFORMANCES WERE IDENTIFIED. STRUCTURAL VALVE DETERIORATION (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. PRIOR INVESTIGATIONS AND EXTENSIVE LITERATURE REVIEW HAVE 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. THERE IS NO EVIDENCE TO SUGGEST A MANUFACTURING DEFECT CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. BASED ON THE INFORMATION AVAILABLE, THE ROOT CAUSE REMAINS INDETERMINABLE AS NO PATIENT OR PROCEDURAL FACTORS KNOWN TO CAUSE OR CONTRIBUTE TO SVD WERE REPORTED. SINCE NO EDWARDS DEFECT WAS IDENTIFIED, CORRECTIVE OR PREVENTATIVE ACTIONS ARE NOT REQUIRED.

    Description of Event or Problem · 0

    EDWARDS LIFESCIENCES MAINTAINS AN IMPLANT PATIENT REGISTRY (IPR). 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. IT WAS REPORTED FROM CANADA VIA THE IMPLANT PATIENT REGISTRY THAT THIS VALVE MODEL 290021MM, IMPLANTED IN AORTIC POSITION, WAS EXPLANTED FROM THIS 76-Y-O PATIENT AFTER AN IMPLANT DURATION OF 6 YEARS AND 5 MONTHS DUE TO CALCIFICATION LEADING TO STENOSIS. THE PATIENT PRESENTED WITH HEART FAILURE PRIOR TO THE INTERVENTION. ANOTHER 21MM BIOPROSTHETIC VALVE WAS IMPLANTED IN REPLACEMENT. AS REPORTED BY THE SURGEON, THE PATIENT SADLY PASSED AWAY AFTER THE REDO SURGERY, STATING THAT THE POSTOPERATIVE MORTALITY WAS RELATED TO THE FAILURE OF THE PROSTHESIS AND THE NEED FOR REPEAT SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5514 SEEH11 REPLACEMENT HEART-VALVE DYE EDWARDS LIFESCIENCES 2900

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female Required Intervention| H| D