BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEE H11

    MDR report key: 19810698 · Received July 23, 2024

    Report

    Report Number
    2015691-2024-05587
    Event Type
    Injury
    Date Received
    July 23, 2024
    Report Date
    September 4, 2024
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    H11
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ATTEMPTS TO RETRIEVE ADDITIONAL INFORMATION WERE UNSUCCESSFUL. THE CAUSE OF THE EVENT CANNOT BE DETERMINED.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED TO EDWARDS FOR EVALUATION AS IT REMAINS IMPLANTED. ATTEMPTS TO RETRIEVE ADDITIONAL INFORMATION WERE UNSUCCESSFUL. 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 EVENTS. TRENDS ARE MONITORED ON A MONTHLY BASIS AND IF ACTION IS REQUIRED, APPROPRIATE INVESTIGATION WILL BE PERFORMED. D1./D4./G5. THIS DEVICE IS NOT SOLD OR MARKETED IN THE UNITED STATES; HOWEVER, IT IS SIMILAR TO THE BRAND CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS, MODEL# 2800, PMA# P860057/S001.

    Description of Event or Problem · 0

    EDWARDS RECEIVED INFORMATION THAT A PATIENT WITH A 25MM 2900TFXJ AORTIC VALVE HAS BEEN EVALUATED FOR A VALVE IN-VALVE PROCEDURE AFTER AN IMPLANT FOR UNKNOWN PERIOD DUE TO UNKNOWN REASON. THE DATE OF PLANNED TAVR IS UNKNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2484229 SEE H11 REPLACEMENT HEART-VALVE DYE EDWARDS LIFESCIENCES SEE H11 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other| L