BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    Z-MED II

    MDR report key: 17521351 · Received August 12, 2023

    Report

    Report Number
    MW5128299
    Event Type
    Malfunction
    Date Received
    August 12, 2023
    Report Date
    November 15, 2017
    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 WITH DELIVERY CATHETER SYSTEM (DCS), MODERATE PARAVALVULAR LEAK (PVL) OCCURRED AFTER THE VALVE WAS PLACED. A 24-MILLIMETER (MM) BALLOON WAS USED FOR THE FIRST POST BALLOON AORTIC VALVULOPLASTY (BAV). THE FIRST BAV WAS NOT SUCCESSFUL AND A SECOND POST BAV WAS PERFORMED WITH A 25-MM Z-MED II BALLOON. THE SECOND BALLOON WAS RETRACTED WITHOUT FULLY DEFLATING, CAUSING THE VALVE TO DISLODGE TO THE ASCENDING AORTA. THE DISLODGEMENT WAS CONFIRMED ON ULTRASOUND. A SECOND VALVE WAS IMPLANTED AND THE DISLODGED VALVE WAS PULLED DOWN TO THE DESCENDING AORTA BY TWO SNARES. NO ADDITIONAL 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
    2182214 Z-MED II BALLOON AORTIC VALVULOPLASTY OZT B. BRAUN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown