BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLEGRA

    MDR report key: 17535994 · Received August 12, 2023

    Report

    Report Number
    MW5142886
    Event Type
    Malfunction
    Date Received
    August 12, 2023
    Report Date
    December 7, 2017
    Manufacturer
    NVT GMBH
    Product Code
    FMA
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    MEDTRONIC RECEIVED INFORMATION THAT IMMEDIATELY FOLLOWING THE IMPLANT OF A 31 MM NVT ALEGRA TRANSCATHETER AORTIC VALVE, THE VALVE EMBOLIZED IN THE DIRECTION OF THE AORTA AFTER RETRIEVAL OF THE DELIVERY CATHETER SYSTEM (DCS). THE VALVE WAS HELD WITH A SNARE WHILE AN ADDITIONAL VALVE WAS IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. (B)(4). 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
    1216844 ALLEGRA DEPRESSOR, TONGUE, NON-SURGICAL FMA NVT GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown