BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDURANT II STENT GRAFT

    MDR report key: 9080481 · Received September 18, 2019

    Report

    Report Number
    9612164-2019-03956
    Event Type
    Death
    Date Received
    September 18, 2019
    Date of Event
    August 5, 2019
    Report Date
    November 4, 2019
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MEDTRONIC RECEIVED THE FOLLOWING INFORMATION FROM THE JOURNAL ARTICLE ENTITLED: ¿¿MEDULLARY ISCHEMIA AFTER ENDOVASCULAR PROCEDURE OF INFRARENAL AORTA IN A PATIENT WITH DUAL ANTICOAGULANT AND ANTIPLATELET THERAPY: A CASE REPORT¿¿. ERIKA D. PÉREZ-RIVEROS, CESAR A. CARDONA-MONTES, CARLOS A. ZAPATA-ÁLVAREZ, WENDY L. SOTELO-HERNÁNDEZ AND ALIRIO R. BASTIDAS-GOYES. JOURNAL OF MEDICAL CASE REPORTS 2019 13 DOI.ORG/10.1186/S13256-019-2168-7. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    AN ENDURANT II STENT GRAFT WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ANEURYSM OF THE INFRARENAL AORTA AND LEFT PRIMITIVE ILIAC ARTERY. A RIGHT HYPOGASTRIC ARTERY EMBOLIZATION WAS ALSO CARRIED OUT DURING THE PROCEDURE. IT WAS REPORTED THAT THE PATIENT RECEIVED POSTOPERATIVE ANTICOAGULANT THERAPY WITH LITTLE ADHERENCE TO THE TREATMENT. IT WAS REPORTED THAT THE PATIENT PRESENTED EMERGENTLY TWO MONTHS AFTER THE INDEX PROCEDURE WITH SUDDEN PAIN AND SIGNS OF ISCHEMIA. THE PATIENT WAS DIAGNOSED WITH AN EXACERBATION OF THEIR CHRONIC PERIPHERAL ARTERIAL DISEASE WITH MODERATE ATHEROMATOUS PROCESS OF LOWER LIMB ARTERIES, WITH ACUTE LEFT FEMORAL POPLITEAL ARTERY OCCLUSION. THE PATIENT WAS TREATED WITH MEDICATION WITH A GRADUAL IMPROVEMENT OF LIMB ISCHEMIA, HOWEVER, FORTY-EIGHT HOURS LATER THE PATIENT PRESENTED WITH SPINAL CORD INFARCTION AND COMPLETE PARALYSIS. TWENTY-FOUR HOURS LATER DESPITE ANTI-HYPERTENSIVE TREATMENT THE PATIENT PRESENTED WITH HYPERTENSIVE EMERGENCY WITH ACUTE TARGET ORGAN DAMAGE. CEREBRAL CT ANGIOGRAPHY SHOWED HEMORRHAGE AND A HEMATOMA. THE PATIENT WAS DISCHARGED WITH UNRESOLVED PARALYSIS AND MILD COGNITIVE IMPAIRMENT. IT WAS REPORTED THAT SEVEN MONTHS LATER WITH PROGRESSIVE WORSENING OF COMPLICATIONS OF HIS DISEASE WITH DEPRESSION, RECURRENT INFECTIONS, AND SKIN ULCERS, THE PATIENT DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    874912 ENDURANT II STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Death| S