BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NI

    MDR report key: 24259668 · Received February 4, 2026

    Report

    Report Number
    2015691-2026-10790
    Event Type
    Injury
    Date Received
    February 4, 2026
    Report Date
    March 12, 2026
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDED INFORMATION TO H6. THERE IS NO EVIDENCE TO SUGGEST A MANUFACTURING DEFECT CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. BASED ON THE INFORMATION AVAILABLE, A DEFINITIVE ROOT CAUSE CANNOT BE CONCLUSIVELY DETERMINED.

    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 EVENTS. TRENDS ARE MONITORED ON A THE INVESTIGATION IS STILL IN PROGRESS; THEREFORE, A CONCLUSION HAS YET TO BE ESTABLISHED. SEE ATTACHMENT FOR ARTICLE.

    Description of Event or Problem · 0

    THROUGH THE REVIEW OF THE MEDICAL ARTICLE: TRANSCATHETER AORTIC VALVE IMPLANTATION IN SMALL SURGICAL AORTIC PROSTHESIS FOR SMALL BODY SIZE PATIENTS. THIS EVENT IS TO CAPTURE CARPENTIER EDWARDS PERICARDIUM (CEP) VALVES (10 PATIENTS) PATIENTS WITH PREVIOUSLY IMPLANTED CEP AORTIC VALVES UNDERWENT VALVE-IN-VALVE PROCEDURES DUE TO PROSTHETIC VALVE FAILURE. AMONG THEM, FOUR (4) PATIENTS HAD A 19MM CEP VALVE, AND ALL FOUR RECEIVED A 23MM NON-EDWARDS TRANSCATHETER VALVE AS A REPLACEMENT. ADDITIONALLY, SIX (6) PATIENTS HAD A 21MM CEP VALVE, AND ALL SIX RECEIVED A 23MM NON-EDWARDS TRANSCATHETER VALVE AS A REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318013 NI REPLACEMENT HEART-VALVE DYE EDWARDS LIFESCIENCES NI NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening| R| H