BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDURANT II

    MDR report key: 3841196 · Received May 30, 2014

    Report

    Report Number
    2953200-2014-01085
    Event Type
    Death
    Date Received
    May 30, 2014
    Date of Event
    May 7, 2014
    Report Date
    May 7, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF A 5.2 CM DIAMETER ABDOMINAL AORTIC ANEURYSM. VESSEL MORPHOLOGY IS UNKNOWN. IT WAS REPORTED THAT THE PHYSICIAN IMPLANTED THE STENT GRAFT. NO COMPLICATIONS WERE NOTED DURING THE PROCEDURE. SHORTLY AFTER THE PROCEDURE, THE PATIENT CODED AND CPR WAS ADMINISTERED. THE PATIENT RECOVERED AND WAS FINE. THE PHYSICIAN BELIEVED THE PATIENT HAD A VASO VAGAL EPISODE, OR PERHAPS REACTED TO THE WIRE MANIPULATION FROM THE PROCEDURE. IT WAS REPORTED THAT THERE WAS A LOT OF WIRE MANIPULATION DURING THE PROCEDURE, DUE TO DIFFICULTY ADVANCING THE WIRE FROM THE LEFT ILIAC ARTERY UP INTO THE DESCENDING AORTA. THE PHYSICIAN BELIEVED THE DIFFICULTY WAS CAUSED BY VESSEL TORTUOSITY AND A POSSIBLY DISEASED AORTA. FIVE DAYS AFTER THE INDEX PROCEDURE, THE PATIENT LOST CONSCIOUSNESS WHILE AT HOME, AND PARAMEDICS RESPONDED. AT THE HOSPITAL, A CT SCAN WAS PERFORMED, REVEALING A DISTAL DESCENDING THORACIC AORTIC ANEURYSM RUPTURE. THE PATIENT CODED AGAIN WHILE BEING PREPPED FOR EMERGENT IMPLANT OF A TAA GRAFT, AND DIED BEFORE THE GRAFT COULD BE IMPLANTED. THE PHYSICIAN BELIEVES THAT THE PARAMEDIC'S APPLICATION OF CPR TO THE CHEST MAY HAVE WEAKENED THE THORACIC AORTA AND CAUSED THE RUPTURE. THE PHYSICIAN HAD BEEN AWARE OF THE THORACIC AORTIC ANEURYSM PRIOR TO THE INDEX PROCEDURE TO TREAT THE ABDOMINAL AORTIC ANEURYSM, AND HAD PLANNED TO TREAT IT SIX MONTHS AFTER THE INDEX PROCEDURE, AS THE PATIENT DID NOT WANT IT TREATED FIRST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319328 ENDURANT II SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V03014889

    Patients

    Seq Age Sex Outcome Treatment
    1 00083 YR Death| R