BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDURANT ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 2951118 · Received February 8, 2013

    Report

    Report Number
    2953200-2013-00229
    Event Type
    Death
    Date Received
    February 8, 2013
    Date of Event
    September 15, 2010
    Report Date
    June 8, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: DEATH. CONGESTIVE HEART FAILURE. CONCLUSION: CONGESTIVE HEART FAILURE.

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE EMERGENT ENDOVASCULAR TREATMENT OF AN 8.2 CM DIAMETER FUSIFORM ABDOMINAL AORTIC ANEURYSM APPROXIMATELY 29 MONTHS AGO. THE INFRA-RENAL NECK ANGLE WAS 40 DEGREES. THE AORTIC NECK WAS 21 MM IN DIAMETER AND 18 MM IN LENGTH. THE DISTAL AORTA WAS 46 MM IN DIAMETER. THE ILIAC ARTERIES WERE 11 MM IN DIAMETER BILATERALLY AND THEY WERE MILDLY TORTUOUS. THE FEMORAL ARTERIES WERE 7 MM IN DIAMETER BILATERALLY. IT WAS REPORTED THAT THE PATIENT SUFFERED PRE-OPERATIVELY FROM CONGESTIVE HEART FAILURE. PROBABLY AS RESULT OF A SMALL DOSE OF CONTRAST FLUID AND IV FLUID, DETERIORATION OF CARDIAC FUNCTION. GOOD RESOLUTION AFTER IV DIURETICS WAS GIVEN. THE PATIENT RECOVERED ON SIX DAYS LATER. THE INVESTIGATOR ASSESSED THIS EVENT AS PROCEDURE RELATED AND NOT DEVICE RELATED. THE PATIENT EXPIRED DUE TO CONGESTIVE HEART FAILURE. THE INVESTIGATOR ASSESSED THIS EVENT TO NOT BE DEVICE OR PROCEDURE RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55194 ENDURANT ABDOMINAL STENT GRAFT SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V00530413

    Patients

    Seq Age Sex Outcome Treatment
    1 00069 YR Death