BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDURANT

    MDR report key: 8654107 · Received May 30, 2019

    Report

    Report Number
    9612164-2019-02097
    Event Type
    Malfunction
    Date Received
    May 30, 2019
    Date of Event
    October 18, 2018
    Report Date
    May 30, 2019
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION OBTAINED FROM THE JOURNAL ARTICLE ENTITLED; PROGNOSTIC NOMOGRAM FOR PATIENTS WITH HOSTILE NECK ANATOMY AFTER ENDOVASCULAR ABDOMINAL AORTIC ANEURYSM REPAIR MIN ZHOU, YONGGANG WANG, YONG DING. ANN VASC SURG 2019; 56: 132¿138 DOI: HTTPS://DOI.ORG/10.1016/J.AVSG.2018.07.062. ENDURANT STENT GRAFT SYSTEMS WERE IMPLANTED IN A PATIENT GROUP FOR ENDOVASCULAR AORTIC ANEURYSM REPAIR. AVERAGE NECK ANGULATION WAS 47.7 DEGREES AND AVERAGE NECK LENGTH WAS 30.4 MM.   THE FOLLOWING ADVERSE EVENTS WERE OBSERVED IN THE PATIENT GROUP: MALFUNCTIONS: TYPE IA ENDOLEAKS TYPE III ENDOLEAKS ABSTRACT: OBJECTIVE: SINCE THE INTRODUCTION OF ENDOVASCULAR AORTIC ANEURYSM REPAIR (EVAR), THE MORPHOLOGY OF ANEURYSM NECK HAS A GREAT IMPACT ON PROGNOSIS OF PATIENTS WHO UNDERWENT ELECTIVE ABDOMINAL AORTIC ANEURYSM (AAA) REPAIR. IN THIS STUDY, WE AIMED TO ANALYZE THE MORPHOLOGIC FEATURES AND PROGNOSIS AFTER EVAR FOR PATIENTS WITH HOSTILE NECK ANATOMY AND TRIED TO CREATE A NOVEL PROGNOSTIC NOMOGRAM IN PREDICTING EVAR-RELATED ADVERSE EVENTS. METHODS: WE RETROSPECTIVELY REVIEWED 812 PATIENTS WITH INFRA-RENAL AAA WHO UNDERWENT ELECTIVE EVAR PROCEDURES BETWEEN JANUARY 2010 AND DECEMBER 2015 AT OUR SINGLE CENTER AND IDENTIFIED PATIENTS WITH HOSTILE NECK. UNIVARIABLE AND MULTIVARIABLE ANALYSES WERE PERFORMED TO DETERMINE THE SIGNIFICANT PROGNOSTIC FACTORS FOR EVAR-RELATED ADVERSE EVENTS, WHICH WERE THEN INTEGRATED TO BUILD A NOMOGRAM. THE MODEL WAS SUBJECTED TO BOOTSTRAP RESAMPLES FOR INTERNAL VALIDATION. THE DISCRIMINATIVE ABILITY WAS PRESENTED WITH CALIBRATION PLOTS AND MEASURED BY CONCORDANCE INDEX (C-INDEX) AND AREA UNDER THE CURVE (AUC) FROM RECEIVER-OPERATING CHARACTERISTIC CURVE. RESULTS: THE OVERALL EVAR-RELATED ADVERSE EVENTS RATE FOR 323 PATIENTS WITH HOSTILE NECK WAS 12.1%. BY MULTIVARIABLE ANALYSIS, SIGNIFICANT RISK FACTORS OF ADVERSE EVENTS INCLUDED FEMALE (ODDS RATIO [OR], 2.58; 95% CONFIDENCE INTERVAL [CI], 1.18E5.62; P ¼ 0.017), CONICAL NECK (OR, 4.66; 95% CI, 1.5E14.51; P ¼ 0.008), SHORT NECK (OR, 2.71; 95% CI, 1.49E4.94; P ¼ 0.001), AND ANGULATED NECK (OR, 3.26; 95% CI, 1.43E7.43; P ¼ 0.005). A NOMOGRAM WAS DEVELOPED BASED ON THE RESULTS OF MULTIVARIABLE ANALYSIS. CALIBRATION PLOTS PRESENTED AN EXCELLENT AGREEMENT BETWEEN MODEL PREDICTED AND ACTUALLY OBSERVED RISK OF ADVERSE EVENTS AFTER INTERNAL VALIDATION. THE DISCRIMINATION ABILITY OF THIS RISK PREDICTIVE MODEL WAS REASONABLE (C-INDEX ¼ 0.79; AUC ¼ 0.81, 95% CI, 0.73E0.89). CONCLUSIONS: EVAR IS A FEASIBLE AND SAFE TREATMENT FOR MOST OF PATIENTS WITH HOSTILE NECK. WE DEVELOPED AND VALIDATED A NOVEL MODEL FOR PREDICTING THE RISK OF ADVERSE EVENTS AFTER EVAR AND CLARIFIED HIGH-RISK PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447754 ENDURANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR