BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDURANT ILIAC STENT GRAFT SYSTEM

    MDR report key: 2032684 · Received March 25, 2011

    Report

    Report Number
    2953200-2011-00703
    Event Type
    Death
    Date Received
    March 25, 2011
    Date of Event
    February 23, 2011
    Report Date
    February 23, 2011
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B(4). EVALUATION RESULTS AND CONCLUSION: DEATH, SEVERE STENOSIS, VERY DISEASED ARTERIES, A VERY FRAGILE RIGHT ILIAC ARTERY WITH APPROXIMATELY 360 DEGREES OF CALCIUM, HEAVILY CALCIFIED BILATERAL HYPOGASTRIC ARTERIES WITH AN OCCLUSION IN THE LEFT.

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 5.7 MM DIAMETER ABDOMINAL ANEURYSM, A 4 CM DIAMETER RIGHT ILIAC ANEURYSM WITH 3.4 CM LENGTH, AND A 2.8 CM DIAMETER LEFT ILIAC ANEURYSM WITH A 4 CM LENGTH, ONE MONTH AGO. (REFERENCE FILE # 2953200-2011-00702, 2953200-2011-00704 AND 2953200-2011-00705). VESSEL MORPHOLOGY WAS REPORTED AS A VERY LARGE TORTUOUS AORTA WITH SEVERE STENOSIS; VERY DISEASED ARTERIES; A VERY FRAGILE RIGHT ILIAC ARTERY WITH APPROXIMATELY 360 DEGREES OF CALCIUM; HEAVY CALCIFIED BILATERAL HYPOGASTRIC ARTERIES WITH AN OCCLUSION IN THE LEFT. THE PATIENT TOLERATED THE ENDOVASCULAR PROCEDURE WELL AND THERE WAS EXCELLENT FLOW DISTALLY BILATERALLY. THE FEET WERE WARM WITH EXCELLENT CAPILLARY REFILL. TWO DAYS POST-IMPLANTATION, THE PATIENT HAD POOR DISTAL OUTFLOW AND ISCHEMIA OF THE RIGHT AND LEFT LEG, NECESSITATING A RIGHT ABOVE-KNEE AMPUTATION. THE OPERATIVE REPORT DOCUMENTS THAT THE PATIENT HAD DISSEMINATED INTRAVASCULAR COAGULATION, SEVERE SEPSIS, ACIDOSIS, MULTISYSTEM ORGAN FAILURE, AND BILATERAL LEG ISCHEMIA. THE PATIENT EXPIRED THREE DAYS AFTER IMPLANT. THE PHYSICIAN STATED THAT THIS PATIENT HAD SEVERE CLAUDICATION, AND PROBABLY NEEDED A FEMORAL-POPLITEAL BYPASS ALONG WITH THE STENT GRAFT IMPLANTATION. HE ALSO STATED THAT THE PATIENT'S ISCHEMIC LEG PROBABLY LED TO THE MULTISYSTEM ORGAN FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDURANT ILIAC STENT GRAFT SYSTEM MIH MEDTRONIC IRELAND NA V00829359

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Death