BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS COMMAND DELIVERY SYSTEM TAVR SHEATH

    MDR report key: 23777203 · Received December 10, 2025

    Report

    Report Number
    MW5180310
    Event Type
    Injury
    Date Received
    December 10, 2025
    Date of Event
    December 3, 2025
    Report Date
    December 5, 2025
    Manufacturer
    EDWARDS LIFE SCIENCES/EDWARDS LIFESCIENCES LLC
    Product Code
    NPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    AN 85 Y/O M ADMITTED FOR TRANSCATHETER AORTIC VALVE REPLACEMENT DUE TO SEVERE AORTIC VALVE STENOSIS. DURING THE PROCEDURE, THE BALLOON ON THE DEVICE RUPTURED. THE VALVE WAS SEATED WITHOUT DIFFICULTY. HOWEVER, WHEN REMOVING THE SHEATH, THE BALLOON BECAME LODGED IN THE FEMORAL ARTERY. THE CV SURGEON WAS ON STANDBY AND DID AN ARTERIAL CUT DOWN AFTER THE PATIENT WAS INTUBATED. ONCE HE IDENTIFIED THE IMPACTED BALLOON, THE SURGEON FELT THAT VASCULAR SURGERY WAS MORE APPROPRIATE TO REMOVE THE BALLOON. VASCULAR SURGEONS RESPONDED AND REMOVED THE BALLOON; THE CV SURGEON CLOSED THE WOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2695275 EDWARDS COMMAND DELIVERY SYSTEM TAVR SHEATH AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFE SCIENCES/EDWARDS LIFESCIENCES LLC 9755RSL

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention