BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NI

    MDR report key: 18740569 · Received February 20, 2024

    Report

    Report Number
    2015691-2024-01165
    Event Type
    Injury
    Date Received
    February 20, 2024
    Date of Event
    December 13, 2022
    Report Date
    March 22, 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

    H10: ADDITIONAL MANUFACTURER 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 DATE OF EVENT. ARTICLE CITATION: VAN DER BIE J, SHARMA SP, VAN STRATEN M, BOS D, HIRSCH A, DIJKSHOORN ML, ADRICHEM R, VAN MIEGHEM NMDA, BUDDE RPJ. RADIOL CARDIOTHORAC IMAGING. 2023 APR 27;5(2):(B)(4). DOI: 10.1148/RYCT.220318. ECOLLECTION 2023 APR. PMID: (B)(4) THE SUBJECT DEVICE IS NOT AVAILABLE FOR EVALUATION AS IT REMAINED IMPLANTED. 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

    H10: ADDITIONAL MANUFACTURER NARRATIVE: THE DEVICE WAS NOT RETURNED TO EDWARDS FOR FURTHER INVESTIGATION, AS THE VALVE REMAINED IMPLANTED DUE TO A VALVE-IN-VALVE REPLACEMENT, AND NO IMAGES OR MEDICAL RECORDS WERE PROVIDED. 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, NON-CALCIFIC 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. SINCE THE IMPLANT DURATION OF THE VALVE IS UNKNOWN, AS A CONSERVATIVE APPROACH, AN IMPLANT DURATION OF BOTH LESS THAN 5 YEARS AND GREATER THAN 5 YEARS IS BEING CONSIDERED. 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 "PHOTON-COUNTING DETECTOR CT IN PATIENTS PRE- AND POST- TRANSCATHETER AORTIC VALVE REPLACEMENT", THE FOLLOWING EVENT WAS IDENTIFIED AS PERTAINING TO AN EDWARDS DEVICE: A 72-YEAR-OLD MALE PATIENT WITH AN UNKNOWN EDWARDS PERIMOUNT VALVE IMPLANTED IN THE AORTIC POSITION UNDERWENT A VALVE-IN-VALVE WITH A NON-EDWARDS TRANSCATHETER VALVE AFTER AN UNKNOWN IMPLANT DURATION DUE TO DEGENERATION. AS REPORTED, EVIDENT BUT LIMITED THICKENING OF ONE VALVE LEAFLET WAS OBSERVED, REPRESENTING HYPOATTENUATING LEAFLET THICKENING WITHOUT A REDUCTION IN LEAFLET MOTION. IT IS UNKNOWN IF THE REPORTED LEAFLET THICKENING REFERS TO THE SURGICAL OR TO THE TAVI VALVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377613 NI REPLACEMENT HEART-VALVE DYE EDWARDS LIFESCIENCES NI

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male Required Intervention| H| L