BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDURANT ILIAC STENT GRAFT SYSTEM

    MDR report key: 2211880 · Received August 10, 2011

    Report

    Report Number
    2953200-2011-01406
    Event Type
    Death
    Date Received
    August 10, 2011
    Date of Event
    July 10, 2011
    Report Date
    July 11, 2011
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL, RESULTS: (GRAFT OCCLUSION, DEATH). (HISTORY OF AORTO-OCCLUSIVE DISEASE). (DEVICE WAS NOT USED TO TREAT AN ABDOMINAL AORTIC ANEURYSM). CONCLUSION: (HISTORY OF AORTO-OCCLUSIVE DISEASE). (DEVICE WAS NOT USED TO TREAT AN ABDOMINAL AORTIC ANEURYSM).

    Description of Event or Problem · 1

    A TALENT CONVERTER STENT GRAFT SYSTEM WAS IMPLANTED INTO A PT FOR THE EMERGENT ENDOVASCULAR TREATMENT OF A SYMPTOMATIC TOTAL OCCLUSION OF THE DISTAL AORTA AND ILIAC ARTERIES BILATERALLY. THE PT WAS NOT HEALTHY AND HAD A HISTORY OF AORTO-OCCLUSIVE DISEASE, AND THERE WAS NO ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THE PHYSICIAN USED A FOGARTY CATHETER AND BALLOONS TO REMOVE CLOT AND OPEN THE RIGHT ILIAC ARTERY, FOLLOWED BY IMPLANTING A TALENT CONVERTER (MFR REPORT #2953200-2011-01405) AND AN ENDURANT ILIAC LIMB (MFR REPORT #2953200-2011-01406), AND THEN PERFORMED A FEMORAL-FEMORAL BYPASS. THE INTERVENTION WAS SUCCESSFUL; HOWEVER, THE FOLLOWING DAY, THE PT BECAME SYMPTOMATIC, AND THE WHOLE AORTA, INCLUDING BOTH STENT GRAFTS, WAS FOUND TO HAVE BECOME TOTALLY OCCLUDED DUE TO THE OCCLUSIVE DISEASE. NO KINKS WERE EVIDENT IN THE STENT GRAFTS. THE PT WAS TAKEN TO SURGERY, AND AN AORTO-BI-FEMORAL PROCEDURE WAS DONE; HOWEVER, THE PT DID NOT TOLERATE THE PROCEDURE AND EXPIRED DUE TO MULTI-ORGAN FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDURANT ILIAC STENT GRAFT SYSTEM MIH MEDTRONIC CARDIOVASCULAR GALWAY NA V00877724

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death