BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    Z-MED

    MDR report key: 17530615 · Received August 12, 2023

    Report

    Report Number
    MW5137533
    Event Type
    Malfunction
    Date Received
    August 12, 2023
    Report Date
    September 16, 2016
    Manufacturer
    B. BRAUN
    Product Code
    OZT
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF A TRANSCATHETER BIOPROSTHETIC VALVE, AS THE 23 MM Z-MED BALLOON WAS DEFLATING, THE BALLOON WAS PULLED IN THE AORTIC DIRECTION AND CAUGHT ON THE EDGE OF THE VALVE RESULTING IN THE VALVE DISLODGING INTO THE SINUS OF VAISAIVA (SOV). SUBSEQUENTLY, THE VALVE WAS SNARED INTO THE ASCENDING AORTA AND A SECOND TRANSCATHETER BIOPROSTHETIC 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
    727781 Z-MED BALLOON AORTIC VALVULOPLASTY OZT B. BRAUN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown