BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDURANT ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 2974296 · Received February 22, 2013

    Report

    Report Number
    2953200-2013-00318
    Event Type
    Death
    Date Received
    February 22, 2013
    Date of Event
    January 27, 2013
    Report Date
    January 29, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: INHERENT RISK OF PROCEDURE (DEATH, ISCHEMIA).

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 7.4 CM DIAMETER ABDOMINAL AORTIC DISSECTION APPROXIMATELY ONE MONTH AGO. THE AORTIC NECK WAS 22 MM IN DIAMETER AND TAPERED WITH A LENGTH OF 48 MM. THE DISTAL AORTA WAS 25 MM IN DIAMETER. THE RIGHT ILIAC ARTERY WAS 18 MM IN DIAMETER AND THE LEFT ILIAC ARTERY WAS 14 MM IN DIAMETER. THE RIGHT FEMORAL ARTERY WAS 9 MM IN DIAMETER AND THE LEFT WAS 8 MM. THERE WAS NO CALCIFICATION OR CIRCUMFERENTIAL THROMBUS. IT WAS REPORTED THAT THE PATIENT EXPIRED FOUR DAYS POST IMPLANT. THE CIRCUMSTANCES OF THE DEATH INCLUDED SHOCK, INFERIOR MESENTERIC ISCHEMIA, AGE, AND CATASTROPHIC CLINICAL CONDITION. THE PRIMARY CAUSE OF DEATH WAS REPORTED TO BE MESENTERIC INFARCTION: LEFT COLON NECROSIS. ANGIOGRAPHY SHOWED NO ABNORMALITIES OF THE STENT GRAFT, NO INTERNAL ILIAC THROMBOSIS, AND NO SIGNS OF EMBOLISM. THE INVESTIGATOR ASSESSED THE DEATH TO BE RELATED TO THE ANEURYSM AND NOT RELATED TO THE DEVICE OR THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77714 ENDURANT ABDOMINAL STENT GRAFT SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V03034289

    Patients

    Seq Age Sex Outcome Treatment
    1 00085 YR Death