BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDURANT

    MDR report key: 3844264 · Received June 2, 2014

    Report

    Report Number
    2953200-2014-01107
    Event Type
    Death
    Date Received
    June 2, 2014
    Date of Event
    December 30, 2013
    Report Date
    May 12, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION OBTAINED FROM THE JOURNAL ARTICLE ENTITLED; OBESITY AS AN INDEPENDENT PREDICTOR OF OUTCOME AFTER ENDOVASCULAR ABDOMINAL AORTIC ANEURYSM REPAIR. ATHANASIOS SARATZIS, MAHMUD SAEDON, NIKOLAOS MELAS, GEORGE D. KITAS, AND ASIF MAHMOOD, ANN VASC SURG 2014; 28: 816¿822 AN ENDURANT STENT GRAFT SYSTEMS WAS IMPLANTED IN PATIENTS FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. DURING THE RETROSPECTIVE STUDY THE FOLLOWING ADVERSE EVENTS WERE OBSERVED: DEATH, BLOOD TRANSFUSION, WOUND INFECTION, THROMBOSIS, STROKE, TYPE I AND II ENDOLEAK, ISCHEMIA, MI, SEPSIS. BACKGROUND: OBESITY IS INCREASINGLY COMMON IN PATIENTS REFERRED FOR THE MANAGEMENT OF AN ABDOMINAL AORTIC ANEURYSM (AAA). EVIDENCE OF THE EFFECT OF OBESITY ON OUTCOMES AFTER ENDOVASCULAR REPAIR (EVAR) IS NOT WELL ESTABLISHED. WE SOUGHT TO COMPARE THE IMMEDIATE AND MIDTERM OUTCOMES OF ELECTIVE EVAR BETWEEN OBESE AND NONOBESE PATIENTS IN A CASE CONTROL STUDY. METHODS: PATIENTS UNDERGOING ELECTIVE EVAR WERE DIVIDED IN 2 GROUPS: OBESE (DEFINED AS A BODY MASS INDEX [BMI] _30 KG/M2) AND NONOBESE (MEAN BMI [KG/M2] ± SD: 33 ± 1 VS 25 ±3). BOTH GROUPS WERE CASE-MATCHED FOR AGE, SEX, SMOKING, AND AAA DIAMETER. ONE HUNDRED FIFTY-NINE PATIENTS WERE INCLUDED (MEAN AGE: 69 ± 9 YEARS; 10 WOMEN [9%]; MEAN BMI: 28 ± 5 KG/M2; 53 WERE OBESE AND 106 WERE NONOBESE). ALL ANEURYSMS WERE SUCCESSFULLY EXCLUDED. MEAN FOLLOW-UP WAS 34 ± 13 MONTHS. RESULTS: ALL PATIENTS WHO DEVELOPED A COMPLICATION WITHIN THE PERIOPERATIVE PERIOD (_30 DAYS) WERE OBESE (P ¼ 0.01). THIRTEEN PATIENTS (8.2%) DIED DURING FOLLOW-UP (8 OBESE VERSUS 5 NONOBESE; P ¼ 0.76). SURVIVAL AND NONEPROCEDURE-RELATED MORBIDITY DID NOT DIFFER SIGNIFICANTLY BETWEEN THE OBESE AND NONOBESE GROUPS (P ¼ 0.64 AND 0.16; LOG-RANK TEST). BMI WAS NOT ASSOCIATED WITH MORTALITY OR NONEPROCEDURE-RELATED MORBIDITY ON MULTIVARIATE ANALYSIS (MORTALITYDHAZARD RATIO: 1.0 [95% CONFIDENCE INTERVAL: 0.9E1.2]; P ¼ 0.37; NONEPROCEDURE RELATED MORBIDITY HAZARD RATIO: 1.0 [95% CONFIDENCE INTERVAL: 0.9E1.1], P ¼ 0.2). CONCLUSIONS: THIS IS THE FIRST CASE CONTROL STUDY TO ASSESS THE INDEPENDENT IMPACT OF OBESITY IN THE OUTCOME AFTER EVAR. NO DIFFERENCE WAS DOCUMENTED WITH REGARDS TO MORTALITY OR NONE ANEURYSM-RELATED MORBIDITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321924 ENDURANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 Death