BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT II

    MDR report key: 4746014 · Received May 4, 2015

    Report

    Report Number
    2953200-2015-00826
    Event Type
    Injury
    Date Received
    May 4, 2015
    Date of Event
    June 1, 2012
    Report Date
    April 27, 2015
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PERIAORTITIS AS A RARE COMPLICATION AFTER ENDOVASCULAR ANEURYSM REPAIR. ANDREAS FRECH, MD; ALEXANDRA GRATL, MD; GUSTAV FRAEDRICH, MD; BERNHARD GLODNY, MD; JOSEF KLOCKER, MD. DOI: 10.1161/CIRCULATIONAHA.114.014771. AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED. THE FOLLOWING ADVERSE EVENTS WERE OBSERVED: PERIAORTITIS, PERIAORTIC INFLAMMATION, HYDRONEPHROSIS, OBSTRUCTION OF THE LEFT URETER. A 6.5-CM ASYMPTOMATIC INFRARENAL AORTIC ANEURYSM WAS DETECTED BY CONTRAST-ENHANCED COMPUTED TOMOGRAPHY (CT) SCAN IN A (B)(6)-YEAR¿OLD PATIENT. INITIALLY, THERE WERE NO SIGNS OF AORTIC OR PERIAORTIC INFLAMMATION (FIGURE 1), AND COMPLETE BLOOD CELL COUNT, RENAL FUNCTION, AND C-REACTIVE PROTEIN LEVELS WERE NORMAL. ANEURYSM REPAIR WAS INDICATED, AND THE PATIENT UNDERWENT ENDOVASCULAR ANEURYSM REPAIR USING AN AORTO-BI-ILAC STENT GRAFT (ENDURANT II, MEDTRONIC INC, MINNEAPOLIS, MN). ROUTINE FOLLOW-UP CONTRAST-ENHANCED CT SCAN WAS PERFORMED ON THE THIRD POSTOPERATIVE DAY AND SHOWED CORRECT STENT GRAFT POSITION WITHOUT EVIDENCE OF ABNORMALITIES (FIGURE 2). AT ROUTINE FOLLOW-UP AFTER 3 MONTHS, THE PATIENT PRESENTED WITH BACK PAIN. CONTRAST-ENHANCED CT SCAN DEMONSTRATED PERIAORTIC INFLAMMATION AND HYDRONEPHROSIS GRADE I TO II ON THE LEFT SIDE ATTRIBUTED TO AN OBSTRUCTION OF THE LEFT URETER (FIGURE 3). BLOOD TEST REVEALED A C-REACTIVE PROTEIN LEVEL OF 3.8 MG/DL AND A NEWLY ELEVATED SERUM CREATININE LEVEL OF 1.4 MG/DL (ESTIMATED GLOMERULAR FILTRATION RATE, 50 ML/MIN PER METER SQUARED). URETERIC OBSTRUCTION WAS TREATED CONSERVATIVELY. SUSPECTING A PERIAORTITIS, THE PATIENT WAS COMMENCED ON CORTICOSTEROIDS USING PREDNISOLONE (INITIAL DOSE, 80 MG/D; MAINTENANCE DOSE, 4 MG/D). WE PERFORMED ANOTHER CLINICAL EXAMINATION AND CT SCAN 1 MONTH LATER. THE PATIENT WAS FREE OF SYMPTOMS. CT SCAN SHOWED A SIGNIFICANT REDUCTION OF PERIAORTIC INFLAMMATION AND NO MORE EVIDENCE FOR URETERIC OBSTRUCTION (FIGURE 4). RENAL FUNCTION RETURNED TO NORMAL VALUES, AND THE C-REACTIVE PROTEIN LEVEL DROPPED DOWN TO 1.7 MG/ DL. FURTHER EXAMINATIONS, INCLUDING BLOOD TEST AND CT SCAN, WERE DONE 3, 6, AND 12 MONTHS LATER. THE PATIENT WAS STILL FREE OF SYMPTOMS, AND RENAL FUNCTION AND C-REACTIVE PROTEIN LEVEL WERE NORMAL. CT SCAN SHOWED ONGOING REDUCTION OF INFLAMMATION AT MONTH 3 AND A STABILE DISEASE AT MONTHS 6 AND 12 (FIGURE 5). STEROID THERAPY WAS CEASED AFTER 12 MONTHS. PRIMARY INFLAMMATORY ABDOMINAL AORTIC ANEURYSMS PRESENT IN 3% TO 10% OF ALL ABDOMINAL AORTIC ANEURYSMS. 1 IN CONTRAST TO PRIMARY INFLAMMATORY ABDOMINAL AORTIC ANEURYSMS, SECONDARY PERI AORTITIS AFTER ENDOVASCULAR ANEURYSM REPAIR SEEMS TO BE A RARE COMPLICATION. THE EXACT MECHANISM FOR SECONDARY INFLAMMATION AFTER ENDOVASCULAR PROCEDURES REMAINS UNCLEAR. IN A SHEEP MODEL, AN INFLAMMATORY PERIGRAFT RESPONSE AFTER IMPLANTATION OF DACRON COVERED STENT GRAFTS INTO ILIAC VESSELS COULD BE SHOWN. 2 SCHURMANN ET AL2 SHOWED AN INCREASED INCIDENCE OF SERUM ANTIBODIES TO O XIDIZED LOW-DENSITY LIPOPROTEINS. LOW-DENSITY LIPOPROTEINS ARE OFTEN FOUND IN THE ATHEROSCLEROTIC PLAQUES OF THE ABDOMINAL AORTA. CONSECUTIVELY, AN AUTOALLERGIC INFLAMMATION OF THE AORTIC WALL IS SUGGESTED. 3 IT IS CONSIDERED THAT IDIOPATHIC RETROPERITONEAL FIBROSIS (MORBUS ORMOND), PERI ANEURYSMATIC RETROPERITONEAL FIBROSIS, AND SECONDARY INFLAMMATORY ABDOMINAL AORTIC ANEURYSM MAY BE RELATED PA THOLOGIES.4 LINKED TO THE TREATMENT OF THOSE DISORDERS, CORTICOIDS WERE USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290664 ENDURANT II SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 00070 YR Required Intervention