BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDURANT ILIAC STENT GRAFT

    MDR report key: 5002573 · Received August 13, 2015

    Report

    Report Number
    2953200-2015-01307
    Event Type
    Death
    Date Received
    August 13, 2015
    Date of Event
    July 13, 2015
    Report Date
    July 21, 2015
    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 WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 9.1 CM IN DIAMETER ABDOMINAL AORTIC ANEURYSM, 5.5 CM IN DIAMETER LEFT ILIAC ARTERY ANEURYSM AND A 4.4 CM IN DIAMETER 4.4 ILIAC ANEURYSM APPROXIMATELY THREE YEARS AGO. THE PROXIMAL NECK WAS 18-20 MM IN DIAMETER AND 18 MM IN LENGTH. THE LEFT COMMON ILIAC ARTERY WAS 20 MM IN DIAMETER. THE PATIENT PRESENTED EMERGENTLY, A CT REVEALED THE RUPTURE WAS MOST LIKELY IN THE LEFT COMMON ILIAC ARTERY HOWEVER, THE EXACT RUPTURE SITE IS UNKNOWN DUE TO ADHESION OF A HEMATOMA. AFTER THE PATIENT WAS ADMITTED DUE TO THE RUPTURE, PROCEDURE WAS NOT EXECUTED UPON REQUEST FROM THE FAMILY. SINCE NO PROCEDURE WAS EXECUTED, THE PHYSICIAN COULD NOT DETERMINE THE RELATION BETWEEN THE DEVICE AND THE EVENT. THE PHYSICIAN STATED THAT THE PATIENT WAS LOST TO FOLLOW UP AND THAT THERE WAS NO CAUSALITY BETWEEN THIS EVENT CASE AND THE RELEVANT DEVICE. THE CT TAKEN AFTER THE PATIENT WAS ADMITTED TO THE HOSPITAL SHOWED THAT THE DEVICE WAS NOT COMPLETELY ADHERED TO THE VESSEL AND CAUSED CHRONIC TYPE IB ENDOLEAK, BUT THERE WERE TOO MANY HEMATOMAS AND RUPTURED AREA THAT WAS NOT ABLE TO BE IDENTIFIED. THE PHYSICIAN CONCLUDED THAT THE EVENT IS NOT DEVICE RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    534000 ENDURANT ILIAC STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND ENLW1628C124EJ

    Patients

    Seq Age Sex Outcome Treatment
    1 00092 YR Death