BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT STENT GRAFT

    MDR report key: 7078299 · Received December 4, 2017

    Report

    Report Number
    2953200-2017-01920
    Event Type
    Injury
    Date Received
    December 4, 2017
    Date of Event
    June 5, 2017
    Report Date
    December 4, 2017
    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

    THIS INITIAL MDR EVENT WAS SUBMITTED UNDER REPORT NUMBER 2024800-2017-00020 ON (B)(6) 2017. DUE TO THE DUPLICATE REPORT NUMBER, THIS EMDR SUBMISSION FAILED AND IS BEING RESUBMITTED UNDER A DIFFERENT (2032600-2017-00001) REPORT NUMBER AS RECOMMENDED BY CDRH EMDR CONSUMER SAFETY OFFICER.

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEMS WERE IMPLANTED INTO A PATIENT FOR THE ENDOVASCULAR TREATMENT IN THE ABDOMINAL AORTIC ANEURYSMS. ABSTRACT: BACKGROUND ACUTE KIDNEY INJURY (AKI) HAS BEEN FOUND TO BE ASSOCIATED WITH SHORT- AND LONG-TERM MORTALITY AND MORBIDITY IN VARIOUS CLINICAL SETTINGS. HOWEVER, IT IS UNKNOWN WHETHER AKI AFTER ENDOVASCULAR REPAIR OF ABDOMINAL AORTIC ANEURYSMS (EVAR) IS ASSOCIATED WITH POSTOPERATIVE MORTALITY. METHODS THIS OBSERVATIONAL STUDY ANALYZED PATIENTS WHO UNDERWENT EVAR. THE PRIMARY OUTCOME WAS ALL-CAUSE MORTALITY. THE OUTCOMES OF PATIENTS WITH AND WITHOUT POSTOPERATIVE AKI WERE COMPARED USING THE KAPLAN¿MEIER METHOD AND LOG-RANK TEST. FACTORS WITH P < 0.05 ON THE UNIVARIATE ANALYSIS WERE ENTERED INTO THE MULTIVARIATE COX REGRESSION MODEL. PREDICTORS OF AKI WERE ALSO DETERMINED USING COX UNIVARIATE AND MULTIVARIATE ANALYSIS. THE IDENTIFIED PREDICTORS OF AKI WERE EXCLUDED FROM MULTIVARIATE ANALYSIS FOR ALL-CAUSE MORTALITY BECAUSE THESE FACTORS COULD INTERMEDIATE OUTCOME. RESULTS THERE WERE 490 ELIGIBLE PATIENTS. AFTER A FOLLOW UP OF 28.3 (16.8) MONTHS [MEAN (STANDARD DEVIATION)], 62 PATIENTS (12.7%) DIED. AKI OCCURRED IN 59 PATIENTS (12.0%). AKI WAS FOUND BY THE LOG-RANK TEST TO BE ASSOCIATED WITH A SIGNIFICANT INCREASE OF ALL-CAUSE MORTALITY (P < 0.001). PREOPERATIVE ESTIMATED GLOMERULAR FILTRATION RATE, PREOPERATIVE PERIPHERAL VASCULAR DISEASE, AND EMERGENCY SURGERY WERE FOUND TO BE INDEPENDENT PREDICTORS OF AKI AND THESE VARIABLES WERE EXCLUDED FROM THE MAIN ANALYSIS. MULTIVARIATE ANALYSIS SHOWED AKI [HAZARD RATIO (HR) = 1 .19, 95% CONFIDENCE INTERVAL (CI) 1.01¿3.60, P = 0.045] AND TRANSFUSION (HR = 1.05, 95% CI 1.01¿1.09, P = 0.011) WERE INDEPENDENT PREDICTORS OF MORTALITY. CONCLUSIONS IN THE PRESENT STUDY, AKI AND TRANSFUSION WERE ASSOCIATED WITH SIGNIFICANT INCREASES IN ALL-CAUSE MORTALITY AFTER EVAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    857960 ENDURANT STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention