BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NI

    MDR report key: 20169413 · Received September 9, 2024

    Report

    Report Number
    2015691-2024-06926
    Event Type
    Injury
    Date Received
    September 9, 2024
    Date of Event
    January 1, 2009
    Report Date
    October 15, 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: ARTICLE CITATION: HECHT S, ZENSES AS, BERNARD J, TASTET L, COTE N, DE FREITAS CAMPOS GUIMARAES L, PARADIS JM, BEAUDOIN J, O'CONNOR K, BERNIER M, DUMONT E, KALAVROUZIOTIS D, DELAROCHELLIERE R, MOHAMMADI S, CLAVEL MA, RODES-CABAU J, SALAUN E, PIBAROT P. HEMODYNAMIC AND CLINICAL OUTCOMES IN REDO-SURGICAL AORTIC VALVE REPLACEMENT VS. TRANSCATHETER VALVE-IN-VALVE. STRUCT HEART. 2022 OCT 28;6(6):100106. DOI: 10.1016/J.SHJ.2022.100106. PMID: 37288124; PMCID: PMC10242565. THIS IS ONE OF FIVE MANUFACTURER REPORTS BEING SUBMITTED FOR THIS ARTICLE. RELATED REPORT NUMBERS WILL BE PROVIDED IN THE SUPPLEMENTAL REPORTS SUBMITTED FOR THIS ARTICLE. THE DEVICE WAS NOT RETURNED FOR EVALUATION, NO OTHER DETAILS REGARDING THIS EVENT, OR WHAT COMORBIDITIES THE PATIENT HAD, WERE PROVIDED. ATTEMPTS TO RETRIEVE THE DEVICE AND ADDITIONAL INFORMATION WERE UNSUCCESSFUL. THE DATES OF THE EVENTS ARE UNKNOWN; HOWEVER, THE ARTICLE PROVIDED THE FOLLOWING DATE RANGE (FROM 2009 UNTIL 2017). THEREFORE, 1-JAN-2009 IS USED AS THE OCCURRENCE DATE. 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 H6 (INVESTIGATION FINDINGS AND INVESTIGATION CONCLUSIONS) ADDED INFORMATION TO SECTION H10 (RELATED REPORT NUMBERS). H11. ADDITIONAL NARRATIVE/DATA: THE SERIAL NUMBER WAS NOT PROVIDED. THEREFORE, THE DEVICE HISTORY RECORD (DHR) COULD NOT BE REVIEWED. IN ADDITION, THE DEVICE WAS NOT RETURNED TO EDWARDS FOR FURTHER INVESTIGATION, AND NO IMAGES OR MEDICAL RECORDS WERE PROVIDED. STRUCTURAL VALVE DETERIORATION (SVD) IS A LOGICAL AND EXPECTED CONSEQUENCE OF THE CHEMICAL, MECHANICAL, AND IMMUNOLOGICAL PROCESSES ASSOCIATED WITH BIOPROSTHETIC HEART VALVES IMPLANTATION. THE COMMON ENDPOINT OF ALL THESE FACTORS IS CALCIFICATION AND DEGRADATION. SVD IS AN ACQUIRED CONDITION, INTRINSIC TO BIOPROSTHETIC VALVES, CHARACTERIZED BY DETERIORATION OF THE LEAFLETS OR SUPPORTING STRUCTURES, LEADING TO THICKENING, CALCIFICATION, TEARING, OR DISRUPTION OF THE PROSTHETIC VALVE MATERIALS. THESE CHANGES RESULT IN VALVULAR DYSFUNCTION MANIFESTING AS STENOSIS AND/OR REGURGITATION WITH A CONSEQUENT DROP IN HEMODYNAMIC EFFICACY OF THE VALVE. PRIOR INVESTIGATIONS AND EXTENSIVE LITERATURE REVIEW HAVE SHOWN THAT SVD IS PREDOMINANTLY RELATED TO PATIENT FACTORS AND IMPLANT DURATION RATHER THAN TO MANUFACTURING ISSUES. EVENTS RELATED TO DEVICE DESIGN, MANUFACTURING, OR USE ERROR TEND TO MANIFEST AT AN EARLIER IMPLANT DURATION. 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 "HEMODYNAMIC AND CLINICAL OUTCOMES IN REDO-SURGICAL AORTIC VALVE REPLACEMENT VS. TRANSCATHETER VALVE-IN-VALVE", THE FOLLOWING EVENT(S) WAS/WERE IDENTIFIED AS PERTAINING TO AN EDWARDS DEVICE: THREE (3) PATIENTS WITH PERIMOUNT VALVES IMPLANTED IN THE AORTIC POSITION UNDERWENT REDO-SURGICAL AORTIC VALVE REPLACEMENT (SAVR) DUE TO STRUCTURAL VALVE DETERIORATION AFTER AN UNKNOWN IMPLANT DURATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1588230 NI REPLACEMENT HEART-VALVE DYE EDWARDS LIFESCIENCES NI

    Patients

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