BEUDAMED
    FDA Adverse Event Death Summary report: N

    LOTUS EDGE VALVE SYSTEM

    MDR report key: 10775158 · Received November 2, 2020

    Report

    Report Number
    2134265-2020-14528
    Event Type
    Death
    Date Received
    November 2, 2020
    Date of Event
    October 13, 2020
    Report Date
    November 2, 2020
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NPT
    UDI-DI
    08714729960904
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AORTIC DISSECTION AND DEATH OCCURRED. A 23MM LOTUS EDGE VALVE WAS SUCCESSFULLY IMPLANTED. NO INDICATION OF AORTIC DISSECTION WAS PRESENT DURING THE TRANSCATHETER AORTIC VALVE REPLACEMENT PROCEDURE. EARLY IN THE MORNING ON THE DAY FOLLOWING THE IMPLANT PROCEDURE, THE PATIENT WAS TAKEN TO SURGERY TO INVESTIGATE HYPOTENSIVE EVENTS THE PATIENT HAD EXPERIENCED OVERNIGHT. AN AORTIC DISSECTION WAS NOTED BELOW THE LEFT RENAL DOWN TO THE LEFT COMMON ILIAC (LCI). THE PATIENT WAS MADE "DO NOT RESUSCITATE" (DNR) STATUS BY THE FAMILY AND DIED DURING SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1239593 LOTUS EDGE VALVE SYSTEM LOTUS EDGE TM VALVE SYSTEM NPT BOSTON SCIENTIFIC CORPORATION H749LVSUS230 0026041895 08714729960904

    Patients

    Seq Age Sex Outcome Treatment
    1 93 YR Death| O