BEUDAMED
    FDA Adverse Event Death Summary report: N

    SAVVYWIRE

    MDR report key: 21719078 · Received March 28, 2025

    Report

    Report Number
    MW5168333
    Event Type
    Death
    Date Received
    March 28, 2025
    Date of Event
    March 7, 2025
    Report Date
    March 24, 2025
    Manufacturer
    OPSENS INC.
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DURING AN ELECTIVE TAVR (TRANSCATHETER AORTIC VALVE REPLACEMENT) PROCEDURE, SAVVY WIRE TEMPORARY PACING WAS PERFORMED. A FEMORAL ACCESS WAS OBTAINED AND THE CATHETER PLACED IN THE PROPER POSITION TO CROSS THE AORTIC VALVE. A SAVVY WIRE WAS INTRODUCED AND PLACED ON THE VENTRICLE APEX. THE VENDOR REPRESENTATIVES WERE PRESENT FOR THE PROCEDURE AND VERIFIED BOTH VENTRICULAR CAPTURE AND THRESHOLD TESTING. THE VALVE WAS DEPLOYED. DURING DEPLOYMENT OF THE VALVE, VENTRICULAR PACING WAS LOST CAUSING EMBOLIZATION OF THE VALVE. THIS RESULTED IN UNSUCCESSFUL ANCHORING OF THE VALUE. AS A RESULT, THERE WAS INJURY TO THE NATIVE VALVE. THE PATIENT BECAME HYPOTENSIVE, CARDIAC ARRESTED AND WAS NOT ABLE TO BE RESUSCITATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2613059 SAVVYWIRE WIRE, GUIDE, CATHETER DQX OPSENS INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Male Death