BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEE H10

    MDR report key: 19006137 · Received March 29, 2024

    Report

    Report Number
    2015691-2024-02365
    Event Type
    Injury
    Date Received
    March 29, 2024
    Date of Event
    December 30, 2019
    Report Date
    May 3, 2024
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDED INFORMATION TO SECTION H4 (DEVICE MANUFACTURER DATE) UPDATED SECTION H6 (INVESTIGATION FINDINGS) AND H6 (INVESTIGATIONS CONCLUSIONS). A DHR WAS NOT PERFORMED, AS NO INFORMATION REGARDING A DEVICE FAILURE MODE WAS PROVIDED. THEREFORE, A REVIEW OF MANUFACTURING AND /OR DEVICE COMPONENT ISSUES THAT MAY HAVE CONTRIBUTED TO THE REPORTED COMPLAINT IS UNABLE TO BE PERFORMED. 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 CAUSE OF THE EVENT CANNOT BE DETERMINED.

    Additional Manufacturer Narrative · 0

    H10. ADDITIONAL MANUFACTURER NARRATIVE: THIS MODEL IS NOT SOLD OR MARKETED IN THE U.S. HOWEVER, IT IS SIMILAR TO DEVICE: MODEL #2800; BRAND NAME: CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS; PMA #P860057/S001. 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.

    Description of Event or Problem · 0

    EDWARDS RECEIVED NOTIFICATION THAT A 290023MM VALVE IMPLANTED IN AORTIC POSITION WAS EXPLANTED AFTER AN IMPLANT DURATION OF NINE (9) YEARS AND NINE (9) MONTHS FOR UNKNOWN REASON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2388821 SEE H10 REPLACEMENT HEART-VALVE DYE EDWARDS LIFESCIENCES 2900

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female Life Threatening| H| R