BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NI

    MDR report key: 19573331 · Received June 20, 2024

    Report

    Report Number
    2015691-2024-04739
    Event Type
    Injury
    Date Received
    June 20, 2024
    Report Date
    July 25, 2024
    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

    H11: ADDITIONAL MANUFACTURER NARRATIVE: THIS IS ONE OF NINE MANUFACTURER REPORTS BEING SUBMITTED FOR THIS ARTICLE. REFER TO MEDWATCH NUMBER 49641, 49642, 49643, 49644, 49645, 49646, 49648, 49649 FOR ADDITIONAL EVENTS WITHIN THE SAME ARTICLE. THE SUBJECT DEVICE IS NOT AVAILABLE FOR EVALUATION AS IT REMAINS IMPLANTED IN THE PATIENT. THE DATE OF THE EVENT IS UNKNOWN; HOWEVER, THE ARTICLE PROVIDED THE FOLLOWING DATE RANGE ON PAGE 2 OF 11: "(FROM (B)(6) 2020 UNTIL (B)(6) 2023)". THEREFORE, (B)(6) 2020 IS USED AS THE OCCURRENCE DATE. ARTICLE CITATION: ZUBAREVICH, A.; BELTSIOS, E.T.; ARJOMANDI RAD, A.; AMANOV, L.; SZCZECHOWICZ, M.; RUHPARWAR, A.; WEYMANN, A. SUTURELESS AORTIC VALVE PROSTHESIS IN REDO PROCEDURES: SINGLE-CENTER EXPERIENCE. MEDICINA 2023, 59, 1126. HTTPS://DOI.ORG/10.3390/MEDICINA59061126. 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 B4 (DATE OF THIS REPORT), G3 (DATE RECEIVED BY MANUFACTURER), H6 (INVESTIGATION FINDINGS) AND H6 (INVESTIGATIONS CONCLUSIONS). THE SERIAL NUMBER WAS NOT PROVIDED. THEREFORE, THE DEVICE HISTORY RECORD (DHR) COULD NOT BE REVIEWED. 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 RELATED TO A MANUFACTURING DEFICIENCY. IFU REVIEW UNABLE TO BE PERFORMED AS THE MODEL IS UNKNOWN. 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 SUTURELESS AORTIC VALVE PROSTHESIS IN REDO PROCEDURES: SINGLE-CENTER EXPERIENCE, THE FOLLOWING EVENTS WERE IDENTIFIED AS PERTAINING TO AN EDWARDS DEVICE. A 23MM PERIMOUNT VALVE IMPLANTED IN THE AORTIC POSITION WAS EXPLANTED AFTER AN UNKNOWN IMPLANT DURATION DUE TO DEGENERATION. A NON-EDWARDS SUTURELESS TISSUE VALVE WAS SUCCESSFULLY IMPLANTED IN REPLACEMENT. THE PATIENT WAS NOTED AS TO BE DISCHARGED HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2156715 NI REPLACEMENT HEART-VALVE DYE EDWARDS LIFESCIENCES NI

    Patients

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