BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOLDER, HEART-VALVE, PROSTHESIS

    MDR report key: 17525482 · Received August 12, 2023

    Report

    Report Number
    MW5132423
    Event Type
    Malfunction
    Date Received
    August 12, 2023
    Report Date
    February 13, 2018
    Manufacturer
    SORIN
    Product Code
    DTJ
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    MEDTRONIC RECEIVED INFORMATION THAT A TRANSCATHETER BIOPROSTHETIC VALVE WAS IMPLANTED VALVE-IN-VALVE IN A PREVIOUSLY IMPLANTED AORTIC VALVE (SORIN MITROFLOW 21), FOR UNKNOWN REASONS. NO FURTHER ADVERSE PATIENT EFFECTS WERE REPORTED. 702263009. 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
    870438 HOLDER, HEART-VALVE, PROSTHESIS HOLDER, HEART-VALVE, PROSTHESIS DTJ SORIN MITROFLOW 21 AORTIC VALVE

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown