BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEE H10

    MDR report key: 13706650 · Received March 9, 2022

    Report

    Report Number
    2015691-2022-04330
    Event Type
    Injury
    Date Received
    March 9, 2022
    Date of Event
    April 29, 2021
    Report Date
    April 11, 2022
    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

    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 REPORTED EVENTS. TRENDS ARE MONITORED ON A MONTHLY BASIS AND IF ACTION IS REQUIRED, APPROPRIATE INVESTIGATION WILL BE PERFORMED.

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD (DHR) WAS NOT REVIEWED AS THE REPORTED EVENT DOES NOT ALLEGE A MALFUNCTION THAT COULD BE RELATED TO A MANUFACTURING DEFICIENCY AND/OR ONE WAS NOT CONFIRMED THROUGH INVESTIGATION. 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. 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.

    Description of Event or Problem · 0

    EDWARDS RECEIVED NOTIFICATION THAT A 290025MM VALVE IMPLANTED IN THE AORTIC POSITION WAS EXPLANTED AFTER AN IMPLANT DURATION OF 11 YEARS FOR UNKNOWN REASON. AN INSPIRIS RESILIA VALVE WAS IMPLANTED IN REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2758295 SEE H10 REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 2900

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Male Life Threatening| H| R