BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC BIOPROSTHESIS

    MDR report key: 18905983 · Received March 14, 2024

    Report

    Report Number
    2015691-2024-02009
    Event Type
    Injury
    Date Received
    March 14, 2024
    Report Date
    April 5, 2024
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D1./D4./G4. 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. SURGICAL/PERCUTANEOUS INTERVENTION IS INDICATED OR PERFORMED, OR HARM OCCURRED DUE TO THE DEVICE, OR THERE IS A DEVICE MALFUNCTION THAT COULD CAUSE OR CONTRIBUTE TO A SERIOUS INJURY. THIS EVENT IS CONSIDERED A SERIOUS INJURY. THE DEVICE WAS NOT RETURNED FOR EVALUATION, AS IT REMAINS IMPLANTED. THE INVESTIGATION IS STILL IN PROGRESS; THEREFORE, A CONCLUSION HAS YET TO BE ESTABLISHED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY UPON INVESTIGATION COMPLETION.

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: BASED ON THE ADDITIONAL INFORMATION OBTAINED, THIS EVENT IS NO LONGER CONSIDERED REPORTABLE AND THIS CORRECTION IS BEING SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT WITH A 21MM AORTIC VALVE HAS BEEN PLACED UNDER CONSIDERATION FOR A VALVE-IN-VALVE PROCEDURE AFTER AN UNKNOWN IMPLANT DURATION DUE TO REGURGITATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT WITH A 21MM 2900J AORTIC VALVE HAS BEEN PLACED UNDER CONSIDERATION FOR A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF EIGHTEEN (18) YEARS, ONE (1) MONTH DUE TO SEVERE AORTIC REGURGITATION SECONDARY TO STRUCTURAL VALVE DETERIORATION. THE PATIENT PRESENTED WITH HEART FAILURE AND DYSPNEA ON EFFORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1968845 CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC BIOPROSTHESIS REPLACEMENT HEART-VALVE DYE EDWARDS LIFESCIENCES 2900

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Male Hospitalization| L| R