BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDURANT

    MDR report key: 4753964 · Received May 6, 2015

    Report

    Report Number
    2953200-2015-00834
    Event Type
    Death
    Date Received
    May 6, 2015
    Date of Event
    November 25, 2014
    Report Date
    April 15, 2015
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS OBTAINED FROM A JOURNAL ARTICLE; OUTCOMES OF ENDOVASCULAR ABDOMINAL AORTIC ANEURYSM REPAIR IN HIGH-RISK PATIENTS SUNGHO LIM, MD, PEGGE M. HALANDRAS, MD, TAEYOUNG PARK, PHD, YOUNGEUN LEE, BA, PAUL CRISOSTOMO, MD, RICHARD HERSHBERGER, MD, BERNADETTE AULIVOLA, MD, AND JAE S. CHO, MD, MAYWOOD, ILL; AND SEOUL, KOREA. (J VASC SURG 2015;61:862-8). THE FOLLOWING ADVERSE EVENTS WERE OBSERVED RENAL OCCLUSION (INADVERTENT), CONVERSION, DISSECTION, PERFORATION, TYPE I LEAK, ACCESS SITE COMPLICATIONS, DEATH, THROMBOSIS, THROMBOEMBOLISMS, GRAFT INFECTION, AND MIGRATION. OBJECTIVE: ALTHOUGH THE ENDOVASCULAR ANEURYSM REPAIR TRIAL 2 (EVAR-2) DEMONSTRATED NO BENEFIT OF EVAR IN HIGH-RISK (HR) PATIENTS, EVAR IS STILL PERFORMED WIDELY IN THIS PATIENT COHORT. THIS STUDY COMPARES THE MIDTERM OUTCOMES AFTER EVAR IN HR PATIENTS WITH THOSE IN NORMAL-RISK (NR) PATIENTS. IN TURN, THESE DATA ARE COMPARED WITH THE EVAR-2 DATA. METHODS: A RETROSPECTIVE REVIEW FROM JANUARY 2006 TO DECEMBER 2013 IDENTIFIED 247 PATIENTS (75 HR [30.4%], 172 NR [69.6%]) WHO UNDERWENT ELECTIVE EVAR FOR INFRARENAL AORTIC ANEURYSM IN AN ACADEMIC TERTIARY INSTITUTION AND ITS AFFILIATED VETERANS ADMINISTRATION HOSPITAL. THE SAME HR CRITERIA USED IN THE EVAR-2 TRIAL WERE EMPLOYED. OVERALL SURVIVAL, GRAFT RELATED COMPLICATIONS, AND RE-INTERVENTION RATES WERE ESTIMATED BY THE KAPLAN-MEIER METHOD. HR GROUP OUTCOMES WERE COMPARED WITH THE EVAR-2 DATA. RESULTS: HR PATIENTS HAD A LARGER ABDOMINAL AORTIC ANEURYSM SIZE AND HAD A HIGHER PREVALENCE OF CARDIAC DISEASE (P <(><<)> .01), CHRONIC OBSTRUCTIVE PULMONARY DISEASE (P [.02), RENAL INSUFFICIENCY (P <(><<)> .01), AND CANCER (P <(><<)> .01). USE OF ASPIRIN (63% HR VS 66% NR; P [ .6), STATIN (83% HR VS 72% NR; P [ .2), AND BETA-BLOCKERS (71% HR VS 60% NR; P [ .2) WAS SIMILAR; IN THE EVAR-2 TRIAL, THE CORRESPONDING USE OF THESE MEDICATIONS WAS 58%, 42%, AND NOT AVAILABLE, RESPECTIVELY. PERIOPERATIVE MORTALITY (0% HR VS 1.2% NR; P [1.0) AND EARLY COMPLICATION RATES (4% HR VS 6% NR; P [ .8) WERE SIMILAR. IN CONTRAST, PERIOPERATIVE MORTALITY IN THE EVAR-2 TRIAL WAS 9%. AT A MEAN FOLLOW-UP OF 3 YEARS, THE INCIDENCE RATES OF DELAYED SECONDARY INTERVENTIONS FOR ANEURYSM- OR GRAFT-RELATED COMPLICATIONS WERE 7% FOR HR PATIENTS AND 10% FOR NR PATIENTS (P [ .5). THE 1-, 2-, AND 4-YEAR SURVIVAL RATES IN HR PATIENTS (85%, 77%, 65%) WERE LOWER THAN THOSE IN NR PATIENTS (97%, 97%, 93%; P <(><<)> .001), BUT THIS WAS MORE FAVORABLE COMPARED WITH A 36% 4-YEAR SURVIVAL IN THE EVAR-2 TRIAL. NO DIFFERENCE WAS SEEN IN LONG-TERM RE-INTERVENTION-FREE SURVIVAL IN HR AND NR PATIENTS (P [ .8). BACKWARD STEPWISE LOGISTIC REGRESSION ANALYSIS IDENTIFIED FIVE PROGNOSTIC INDICATORS FOR POST-EVAR DEATH: AGE, CHRONIC KIDNEY DISEASE STAGES 4 AND 5, CONGESTIVE HEART FAILURE, HOME OXYGEN USE, AND CURRENT CANCER THERAPY. CONCLUSIONS: EVAR CAN BE PERFORMED IN PATIENTS UNFIT FOR OPEN SURGICAL REPAIR WITH EXCELLENT EARLY SURVIVAL AND LONG-TERM DURABILITY. THESE OUTCOMES IN THE HR GROUP COMPARE MORE FAVORABLY TO THE EVAR-2 TRIAL DATA. HOWEVER, NOT ALL HR PATIENTS FOR OPEN SURGICAL REPAIR DERIVE THE BENEFIT FROM EVAR. THE DECISION TO PROCEED WITH EVAR IN HR PATIENTS SHOULD BE INDIVIDUALIZED, DEPENDING ON THE NUMBER AND SEVERITY OF RISK FACTORS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298090 ENDURANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR Required Intervention