BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT

    MDR report key: 3366078 · Received September 24, 2013

    Report

    Report Number
    2953200-2013-01868
    Event Type
    Injury
    Date Received
    September 24, 2013
    Report Date
    August 30, 2013
    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). RESULTS: INHERENT RISK OF PROCEDURE (STENT GRAFT OCCLUSION, EMBOLI, RENAL FAILURE), PATIENT¿S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (WIDESPREAD MURAL THROMBUS), (CAUSE OF EVENT IS UNKNOWN). CONCLUSION: KNOWN INHERENT RISK OF PROCEDURE (STENT GRAFT OCCLUSION, EMBOLI, RENAL FAILURE),DEVICE FAILURE RELATED TO PATIENT CONDITION (WIDESPREAD MURAL THROMBUS), (CAUSE OF EVENT IS UNKNOWN).

    Description of Event or Problem · 1

    THE EVENT WAS REPORTED AT A CONFERENCE OF JES ((B)(4) ENDOVASCULAR SYMPOSIUM). AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. IT WAS CONFIRMED THE ENTIRE CIRCUMFERENCE OF MURAL THROMBOSIS WAS AT THE DESCENDING THORACIC AORTIC ANEURYSM AND ABDOMINAL AORTIC ANEURYSM WITH MURAL THROMBOSIS JUST BELOW THE PROXIMAL NECK. EVAR (ENDURANT) WAS PERFORMED; THE LEFT EIA STENTING WAS PERFORMED FOR PAD. IMMEDIATELY AFTER EVAR, PATIENT HAD BLUE TOE SYNDROME AND LEG PAIN IN BOTH LEGS. IT WAS ALSO CONFIRMED RENAL FUNCTION DETERIORATION (CR 3.65) AND AN INCREASE IN EOSINOPHIL A SKIN BIOPSY WAS CARRIED OUT. IT WAS DIAGNOSED AS CHOLESTEROL CRYSTAL EMBOLIZATION. AS A RESULT, IT TOOK ABOUT 2 MONTHS FOR RECOVERY OF GENERAL STATUS. CONSERVATIVE TREATMENT DEPRIVED THE PATIENT OF LEG PAIN AND RENAL FUNCTION WAS RECOVERED TO CR LEVEL 2 WITHOUT DIALYSIS. POINTS TO BE CONSIDERED: IN THE ENDOVASCULAR TREATMENT, OCCLUSION IS A COMPLICATION REQUIRES METICULOUS CARE. IT SHOULD BE CAREFULLY CHECKED FOR THE PRESENCE OF A SHAGGY AORTA, CONDITION OF MURAL THROMBUS AND VESSEL CURVATURE WITH PRE-OPERATIVE CT DATA FOR TREATMENT. BESIDES IT IS REQUIRED TO BE CHECKED PULSE RATE OF LEGS FOR BEFORE OPERATION. AFTER OPERATION, IT IS ALSO REQUIRED TO BE CHECKED PULSE RATE OF LEGS AND COLOR CHANGE. ESPECIALLY IN THE CASE OF COILING FOR INTERNAL ILIAC ARTERY, INTERNAL ILIAC AREA SUCH AS BUTTOCKS SHOULD BE CHECKED AS WELL. IN CASE OF LIMB OCCLUSION, POST-OPERATIVE CARE IS NEEDED CONSIDERATION OF POSSIBILITY OF OCCURRENCE OF OCCLUSION SUCH AS INTESTINAL CANAL. WHEN IT IS FOUND ACUTE DETERIORATION OF RENAL FUNCTION AND AN INCREASE IN EOS WITH POST-OPERATIVE BLOOD DRAWING, IT SHOULD BE DOUBT CCE WHICH IS SEVERE DISEASE TO LEAD TO VARIOUS ORGANOPATHY AFTER OCCLUSION OF MICRO-VESSELS BY CHOLESTEREMIA WITH MECHANICAL/CHEMICAL INJURY. MOST OF THE PATIENTS ARE OVER 60 YEAR OLD MALES WHO ARE LIABLE TO CCE IN CASE OF HAVING DISEASE SUCH AS HYPERTENSION, DIABETES, HYPERLIPIDEMIA, GOUT, ARTERIOSCLEROSIS, AORTIC ANEURYSM AND RENAL FAILURE. CCE ASSOCIATED WITH MULTIPLE ORGAN FAILURE IS RATHER POOR PROGNOSIS. STEROID-USE MAY SOMETIMES BE AN EFFECTIVE TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    480920 ENDURANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 00071 YR