BEUDAMED
    FDA Adverse Event Other Summary report: N

    BIOPROSTHETIC VALVE

    MDR report key: 17756808 · Received September 14, 2023

    Report

    Report Number
    MW5145696
    Event Type
    Other
    Date Received
    September 14, 2023
    Report Date
    September 1, 2023
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    LWR
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    (B)(6) RECEIVED INFORMATION THAT AN UNKNOWN TIME FOLLOWING THE IMPLANT OF THIS SURGICAL AORTIC VALVE, A TRANSCATHETER BIOPROSTHETIC VALVE WAS IMPLANTED FOR AN UNKNOWN REASON. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295141 BIOPROSTHETIC VALVE HEART-VALVE, NON-ALLOGRAFT TISSUE LWR ABBOTT MEDICAL TRIFECTA

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown