BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NI

    MDR report key: 17449472 · Received August 3, 2023

    Report

    Report Number
    2015691-2023-15003
    Event Type
    Injury
    Date Received
    August 3, 2023
    Date of Event
    November 30, 2022
    Report Date
    September 8, 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

    H10: ADDITIONAL NARRATIVE: THE DATE OF THE EVENT IS UNKNOWN; HOWEVER, THE ARTICLE WAS RECEIVED FOR PUBLICATION ON (B)(6) 2022. THEREFORE, THE DATE THE ARTICLE WAS RECEIVED FOR PUBLICATION WAS USED AS THE OCCURRENCE DATE. THE SUBJECT DEVICES ARE NOT AVAILABLE FOR EVALUATION AS THEY REMAIN IMPLANTED. ARTICLE CITATION: MATTA A, LEVAI L, RONCALLI J, ELBAZ M, BOUISSET F, NADER V, BLANCO S, CAMPELO PARADA F, CARRIE D AND LHERMUSIER T (2023) COMPARISON OF IN HOSPITAL OUTCOMES AND LONG TERM SURVIVAL FOR VALVE IN VALVE TRANSCATHETER AORTIC VALVE REPLACEMENT VERSUS THE BENCHMARK NATIVE VALVE TRANSCATHETER AORTIC VALVE REPLACEMENT PROCEDURE. FRONT. CARDIOVASC. MED. 10:1113012. DOI: 10.3389/FCVM.2023.1113012. 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

    ADDED INFORMATION TO SECTION H6 (TYPE OF INVESTIGATION) UPDATED SECTION H6 (INVESTIGATION FINDINGS) AND H6 (INVESTIGATIONS CONCLUSION) THE SERIAL NUMBER WAS NOT PROVIDED. THEREFORE, THE DEVICE HISTORY RECORD (DHR) COULD NOT BE REVIEWED. DESPITE DUE DILIGENT ATTEMPTS TO RECEIVE FURTHER INFORMATION REGARDING THIS EVENT, NO ADDITIONAL INFORMATION OR PATIENT DEMOGRAPHICS WAS RECEIVED FROM THE CUSTOMER. TISSUE DEGENERATION-RELATED STRUCTURAL DETERIORATION, EITHER CALCIFIC OR NON-CALCIFIC, ARE COMMON CHRONIC FAILURE MODES FOR THIS TYPE OF BIOPROSTHETIC HEART VALVE. OPERATIONAL MECHANICAL STRESS AND BIOLOGICAL FACTORS ARE GENERALLY BELIEVED TO BE THE MAJOR CONTRIBUTORS TO THE NON-CALCIFIC BIOPROSTHETIC TISSUE DEGENERATION. STRUCTURAL VALVE DETERIORATION (SVD) CAN, AND TYPICALLY DOES, LEAD TO CHRONIC CENTRAL LEAKS OVER A PERIOD OF TIME. SVD IS THE MOST COMMON REASON FOR BIOPROSTHESIS EXPLANT AND ENCOMPASSES MULTIPLE FAILURE MODES, INCLUDING CALCIFICATION, NONCALCIFIC DEGENERATION, DEHISCENCE, CUSP THICKENING OR FIBROSIS, OR A COMBINATION OF THESE. SUCH FAILURE MODES MAY OCCUR SINGULARLY OR CONCOMITANTLY. DEGENERATION-RELATED STRUCTURAL DETERIORATION 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

    THROUGH REVIEW OF MEDICAL ARTICLE "COMPARISON OF IN-HOSPITAL OUTCOMES AND LONG-TERM SURVIVAL FOR VALVE-IN-VALVE TRANSCATHETER AORTIC VALVE REPLACEMENT VERSUS THE BENCHMARK NATIVE VALVE TRANSCATHETER AORTIC VALVE REPLACEMENT PROCEDURE" THE FOLLOWING EVENT WAS IDENTIFIED AS PERTAINING TO AN EDWARDS DEVICE: 26 PATIENTS WITH A CARPENTIER EDWARDS VALVE IMPLANTED IN THE AORTIC POSITION UNDERWENT VALVE-IN-VALVE PROCEDURE DUE TO DEGENERATION AFTER AN UNKNOWN IMPLANT DURATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1508172 NI REPLACEMENT HEART-VALVE DYE EDWARDS LIFESCIENCES NI

    Patients

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