BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NI

    MDR report key: 20528477 · Received October 24, 2024

    Report

    Report Number
    2015691-2024-08087
    Event Type
    Injury
    Date Received
    October 24, 2024
    Date of Event
    May 30, 2023
    Report Date
    November 25, 2024
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H11: ADDITIONAL MANUFACTURER NARRATIVE: THIS IS ONE OF FOUR MANUFACTURER REPORTS BEING SUBMITTED FOR THIS ARTICLE. REFER TO MEDWATCH NUMBER (B)(4) REPORT ID 2015691 2024 08057, (B)(4) REPORT ID 2015691 2024 08058, (B)(4) REPORT ID 2015691 2024 08059 FOR EVENTS WITHIN THE SAME ARTICLE. THE DATE OF THE EVENT IS UNKNOWN. THUS, THE DATE WHEN THE ARTICLE WAS RECEIVED (B)(6) 2023 WAS USED AS THE OCCURRENCE DATE PER (B)(4). SATHANANTHAN J, NIGADE A, MEIER D, NAVARRO D, SPENCER J, LAI A, GILL H, PIRELLI L, WEBB JG, WOOD DA, LUTTER G, PUEHLER T, TANG GHL, FUKUHARA S, SELLERS SL. HYDRODYNAMIC ASSESSMENT OF EXPLANTED DEGENERATED TRANSCATHETER AORTIC VALVES: NOVEL INSIGHTS INTO NONCALCIFIC AND CALCIFIC MECHANISMS. JACC CARDIOVASC INTERV. 2024 JUN 10;17(11):1340-1351. DOI: 10.1016/J.JCIN.2024.04.011. PMID: (B)(4). THE DEVICE WAS NOT RETURNED FOR EVALUATION, NO DETAILS REGARDING WHAT ISSUE WARRANTED THE INTERVENTION, OR WHAT COMORBIDITIES THE PATIENT HAD, WERE PROVIDED. ATTEMPTS TO RETRIEVE THE DEVICE AND ADDITIONAL INFORMATION WERE UNSUCCESSFUL. THE SERIAL NUMBER WAS NOT PROVIDED. THEREFORE, THE DEVICE HISTORY RECORD (DHR) COULD NOT BE REVIEWED. 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 INFORMATION IN SECTION H6 (COMPONENT CODE, INVESTIGATION FINDINGS AND INVESTIGATION CONCLUSIONS). H11. ADDITIONAL NARRATIVE/DATA: THE DEVICE WAS NOT RETURNED FOR EVALUATION, NO DETAILS REGARDING WHAT ISSUE WARRANTED THE INTERVENTION, OR WHAT COMORBIDITIES THE PATIENT HAD, WERE PROVIDED. ATTEMPTS TO RETRIEVE ADDITIONAL INFORMATION WERE UNSUCCESSFUL. THERE IS NO EVIDENCE TO SUGGEST A MANUFACTURING DEFECT CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. BASED ON THE INFORMATION AVAILABLE, A DEFINITIVE ROOT CAUSE CANNOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 0

    THROUGH REVIEW OF MEDICAL ARTICLE "HYDRODYNAMIC ASSESSMENT OF EXPLANTED DEGENERATED TRANSCATHETER AORTIC VALVES." , CORRESPONDING AUTHOR STEPHANIE L. SELLERS ET AL., THE FOLLOWING EVENTS WERE IDENTIFIED AS PERTAINING TO AN EDWARDS DEVICE: A MALE PATIENT OF APPROXIMATELY 64-YEARS-OLD AGE WITH A 25 MM PERIMOUNT MAGNA VALVE IMPLANTED IN AORTIC POSITION UNDERWENT RE-INTERVENTION FOR A VALVE-IN-VALVE PROCEDURE FOR UNKNOWN REASON AFTER UNKNOWN IMPLANT DURATION. A 26MM TRANCATHER VALVE WAS IMPLANTED WITHIN THE PRE-EXISTING SURGICAL DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2579901 NI REPLACEMENT HEART-VALVE DYE EDWARDS LIFESCIENCES NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Hospitalization| R| L