BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NI

    MDR report key: 16972265 · Received May 22, 2023

    Report

    Report Number
    2015691-2023-13137
    Event Type
    Injury
    Date Received
    May 22, 2023
    Date of Event
    April 26, 2023
    Report Date
    June 30, 2023
    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

    ADDITIONAL MANUFACTURER NARRATIVE: THE SUBJECT DEVICE IS NOT AVAILABLE FOR EVALUATION AS IT REMAINS IMPLANTED IN THE PATIENT. 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

    UPDATED SECTION B5 (DESCRIBE EVENT OR PROBLEM), B6 (RELEVANT TESTS/LABORATORY DATA, INCLUDING DATES), H6 (DEVICE CODE(S)).

    Additional Manufacturer Narrative · 0

    H10: ADDITIONAL MANUFACTURER NARRATIVE: 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. CALCIFICATION IS MOST COMMONLY RELATED TO PATIENT FACTORS AND IS NOT USUALLY AN INDICATION OF A DEVICE MALFUNCTION. A DEFINITIVE ROOT CAUSE CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, PATIENT FACTORS LIKELY CAUSED OR CONTRIBUTED.

    Description of Event or Problem · 0

    EDWARDS RECEIVED NOTIFICATION THAT A 78 YEARS OLD PATIENT WITH A 19MM CARPENTIER EDWARDS VALVE IMPLANTED IN THE AORTIC POSITION UNDERWENT A DOBLE VALVE-IN-VALVE (VIV) PROCEDURE AFTER AN IMPLANT DURATION OF SEVEN (7) YEARS AND NINETEEN (19) MONTHS DUE TO STENOSIS AND PROBABLY ENDOCARDIAL PROCESS. THE PATIENT PRESENTED WITH SEVERE DYSPNEA BEFORE THE VIV PROCEDURE. A 20MM TRANSCATHETER VALVE WAS IMPLANTED WITHIN THE PRE-EXISTING SURGICAL EDWARDS VALVE. THE PATIENT WAS STABLE AT HOME.

    Description of Event or Problem · 0

    EDWARDS RECEIVED NOTIFICATION THAT A 78 YEARS OLD PATIENT WITH A 19MM CARPENTIER EDWARDS VALVE IMPLANTED IN THE AORTIC POSITION UNDERWENT A DOBLE VALVE-IN-VALVE (VIV) PROCEDURE IN AORTIC AND MITRAL POSITION AFTER AN IMPLANT DURATION OF SEVEN (7) YEARS AND NINETEEN (19) MONTHS DUE TO CALCIFIC DEGENERATION LEADING TO STENOSIS AFFECTING BOTH AORTIC AND MITRAL VALVES. THE PATIENT PRESENTED WITH SEVERE DYSPNEA BEFORE THE VIV PROCEDURE. A 20MM TRANSCATHETER VALVE WAS IMPLANTED WITHIN THE PRE-EXISTING SURGICAL EDWARDS VALVE. THE PATIENT WAS DISCHARGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    862566 NI REPLACEMENT HEART-VALVE DYE EDWARDS LIFESCIENCES NI

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Female Life Threatening| R| H