BEUDAMED
    FDA Adverse Event Death Summary report: N

    EDWARDS ESHEATH + INTRODUCER SET

    MDR report key: 19961843 · Received August 12, 2024

    Report

    Report Number
    MW5158303
    Event Type
    Death
    Date Received
    August 12, 2024
    Date of Event
    July 26, 2024
    Report Date
    August 8, 2024
    Manufacturer
    EDWARDS LIFESCIENCES CORP. / EDWARDS LIFESCIENCES LLC.
    Product Code
    DYB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DURING THIS PATIENTS TAVR WHILE GOING UP WITH THE VALVE DELIVERY SYSTEM THE SHEATH MALFUNCTIONED AND SPLIT OPEN - CAUSING THE SYSTEM TO KINK OVER. DR. WAS ABLE TO PULL THE SYSTEM BACK WHICH ALLOWED IT GO STRAIGHTEN BACK OUT. HOWEVER, THE BOTTOM EDGE OF THE VALVE FLARED OUT DURING THAT TIME AND CAUSED A PERFORATION THROUGH THE ILIAC ARTERY. THIS CAUSED THE PATIENT TO START HEMORRHAGING. MASSIVE TRANSFUSION PROTOCOL WAS INITIATED AND CODE BLUE WAS INITIATED WHEN PATIENT LOST PRESSURE. DR. WAS UNABLE TO REMOVE THIS DELIVERY SYSTEM AND SHEATH TO ATTEMPT TO FIX THE PROBLEM WITHOUT POTENTIALLY TEARING THE ILIAC ARTERY THE ENTIRE WAY DOWN BECAUSE OF THE FLARE ON THE VALVE EDGE STICKING OUT. VASCULAR SURGERY WAS CALLED AND OFFERED SUPPORT FOR THIS. HOWEVER, DR. SPOKE WITH FAMILY REGARDING PATIENT'S CURRENT STATUS AND FAMILY FELT IT WAS BEST TO STOP ALL EFFORTS AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1723821 EDWARDS ESHEATH + INTRODUCER SET INTRODUCER, CATHETER DYB EDWARDS LIFESCIENCES CORP. / EDWARDS LIFESCIENCES LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Male Death