BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEE H10

    MDR report key: 17431368 · Received July 31, 2023

    Report

    Report Number
    2015691-2023-14942
    Event Type
    Injury
    Date Received
    July 31, 2023
    Report Date
    September 6, 2023
    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

    THE DEVICE HISTORY RECORD (DHR) WAS UNABLE TO BE PERFORMED, AS THE DEVICE LOT/SERIAL NUMBER WAS NOT PROVIDED. DESPITE MULTIPLE REQUESTS FOR ADDITIONAL INFORMATION FROM THE HEALTHCARE PROVIDER, NO ADDITIONAL DETAILS HAVE BEEN PROVIDED. BASED ON THE INFORMATION AVAILABLE, A DEFINITIVE ROOT CAUSE CANNOT BE CONCLUSIVELY DETERMINED.

    Additional Manufacturer Narrative · 0

    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 SUBJECT DEVICE IS NOT AVAILABLE FOR EVALUATION, AS IT REMAINS IMPLANTED IN THE PATIENT. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT WITH A 21MM 2900J AORTIC VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN UNKNOWN IMPLANT DURATION DUE TO UNKNOWN REASON. THE PROCEDURE WAS PERFORMED WITH A NON-EDWARDS TRANSCATHETER VALVE. THE PATIENT STATUS WAS REPORTED AS UNDER TREATMENT. THE DEVICE WAS NOT RETURNED FOR EVALUATION AS IT REMAINED IMPLANTED. NO FURTHER INFORMATION WAS PROVIDED BY THE DOCTOR, SUCH AS SERIAL NUMBER, IMPLANT DURATION, FAILURE MODE, SYMPTOMS/DIAGNOSIS, PATIENT INFORMATION, OR THE CAUSALITY BETWEEN THE EVENT AND THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1696704 SEE H10 REPLACEMENT HEART-VALVE DYE EDWARDS LIFESCIENCES 2900J

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization| R| L