BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDURANT

    MDR report key: 3953748 · Received July 23, 2014

    Report

    Report Number
    2953200-2014-01448
    Event Type
    Death
    Date Received
    July 23, 2014
    Date of Event
    June 27, 2014
    Report Date
    June 27, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WERE IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF A 7 CM DIAMETER ABDOMINAL AORTIC ANEURYSM. THE EXTERNAL ILIAC ARTERY HAD NO ISSUE HOWEVER, THE PROXIMAL NECK AND COMMON ILIAC ARTERY HAD SEVERE TORTUOSITY. THE PROXIMAL NECK WAS 27-31 MM IN DIAMETER AND 30 MM IN LENGTH. THE LEFT COMMON ILIAC ARTERY WAS 22 MM IN DIAMETER AND THE RIGHT COMMON ILIAC ARTERY WAS 17 MM IN DIAMETER. THE RIGHT AND LEFT EXTERNAL ILIAC ARTERIES MEASURED 10MM IN DIAMETER. THE NECK ANGLE WAS 90 DEGREE. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE FOUR DEVICES WERE IMPLANTED AS PLANNED HOWEVER, A SMALL PROXIMAL TYPE I ENDOLEAK TYPE IA ENDOLEAK WAS OBSERVED. THE PHYSICIAN ATTEMPTED TO IMPLANT AN ENDURANT CUFF BUT IT WAS UNABLE TO BE DELIVERED. THE SAME CUFF WAS AGAIN ATTEMPTED TO BE IMPLANTED FROM THE RIGHT SIDE USING ANOTHER MANUFACTURER¿S 22FR DRY SEAL, WHICH RESULTED IN FAILURE. THE ENDURANT CUFF WAS REMOVED FROM THE PATIENT AND DISCARDED. THE ANGIOGRAPHY SHOWED THAT PROXIMAL TYPE I ENDOLEAK HAD RESOLVED, WHICH MIGHT HAVE OCCURRED DUE TO THE DIFFICULTY OF THE DELIVERY SYSTEM (CUFF) BEING PUSHED UP HARD BY THE PHYSICIAN, MOVING THE BIFURCATE UPWARD. THE ENDURANT LIMB, WHICH HAD BEEN IMPLANTED ON THE RIGHT SIDE HAD SEPARATED AND TYPE III ENDOLEAK OCCURRED. THE PHYSICIAN IMPLANTED AN ENDURANT LIMB AS A BRIDGE AND THE TYPE III ENDOLEAK WAS RESOLVED. AS THE 22FR DRY SEAL WAS REMOVED, THE PATIENT HAD DECREASE IN BLOOD PRESSURE. DURING DECREASED BLOOD PRESSURE, CARDIAC MASSAGE WAS CARRIED OUT WITH PERCUTANEOUS CARDIOPULMONARY SUPPORT (PCPS). THE PHYSICIAN THEN IMPLANTED AND ENDURANT LIMB AND THE DAMAGED SITE IMPROVED. AFTER THAT, THE CAUSE WAS UNKNOWN BUT LEFT SIDE WAS ALSO DAMAGED. THEREFORE, AND ENDURANT LIMB WAS IMPLANTED. THE DAMAGED SITE IMPROVED. THE PROCEDURE WAS COMPLETED HOWEVER, THE PATIENT EXPIRED TWO DAYS LATER. THE PATIENT¿S BLOOD PRESSURE HAD DECREASED DURING REMOVAL OF DRY SEAL BUT THE DOCTOR FROM THE ANESTHESIA DEPARTMENT SEEMED TO CONTROL BLOOD PRESSURE WITH ANTIHYPERTENSIVE DRUG. THE EXACT CAUSE WAS UNKNOWN BUT WOULD BE MAINLY CAUSED BY REMOVAL OF THE DRY SEAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431898 ENDURANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V04238449

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| R