BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDURANT STENT GRAFT SYSTEM

    MDR report key: 5499174 · Received March 14, 2016

    Report

    Report Number
    2953200-2016-00471
    Event Type
    Malfunction
    Date Received
    March 14, 2016
    Date of Event
    November 13, 2015
    Report Date
    February 19, 2016
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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; CHARACTERISTICS AND RISK FACTORS FOR TYPE 2 ENDOLEAK IN AN EAST ASIAN POPULATION FROM A (B)(4) MULTICENTER DATABASE NAOKI FUJIMURA, MD, PHD; HIDEAKI OBARA, MD, PHD; KENTARO MATSUBARA, MD, PHD; SUSUMU WATADA, MD, PHD; SHINTARO SHIBUTANI, MD, PHD; TAKURIN AKIYOSHI, MD, PHD; HIROHISA HARADA, MD, PHD; YUKO KITAGAWA, MD, PHD (CIRC J 2016; 80: 118¿123) ENDURANT STENT GRAFT SYSTEMS WERE IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF ABDOMINAL ANEURYSM REPAIR. THE FOLLOWING ADVERSE EVENTS WERE OBSERVED: TYPE I ENDOLEAK, TYPE II ENDOLEAK AND TYPE IV ENDOLEAK. BACKGROUND: CLINICALLY DISTINCT DIFFERENCES EXIST BETWEEN EAST ASIAN AND CAUCASIAN SUBJECTS, BUT DATA FOR TYPE 2 ENDOLEAK (T2EL) ARE LIMITED IN THE EAST ASIAN POPULATION. THE AIM OF THIS STUDY WAS TO ANALYZE THE CHARACTERISTICS OF EAST ASIAN T2EL USING A (B)(4) MULTICENTER DATABASE. METHODS AND RESULTS: RETROSPECTIVE ANALYSIS OF 832 ENDOVASCULAR ANEURYSM REPAIRS PERFORMED FROM 2008 TO 2014 WERE CONDUCTED. T2EL WAS OBSERVED IN 234 CASES (28.1%), AND IN 32 CASES (3.8%) IT LED TO SAC EXPANSION >5 MM CAUSED BY ISOLATED T2EL (MEDIAN FOLLOW-UP, 35.6 MONTHS). ON UNIVARIATE AND MULTIVARIATE ANALYSIS, NON-SMOKER STATUS (ODDS RATIO [OR], 2.216; P <(><<)>0.001), EXCLUDER STENT GRAFT (OR, 2.027; P<(><<)>0.001), AND T2EL AT FINAL ANGIOGRAM (OR, 2.080; P<(><<)>0.001) WERE RISK FACTORS FOR T2EL. ON MULTIVARIATE ANALYSIS FOR ISOLATED T2EL WITH SAC EXPANSION, ONLY NON-SMOKER STATUS REMAINED (OR, 2.671; P<(><<)>0.001). OTHER THAN T1EL, ISOLATED T2EL WAS THE MOST SIGNIFICANT RISK FACTOR FOR SAC EXPANSION (OR, 18.486; P<(><<)>0.001). FURTHERMORE, OUT OF 11 TRANSARTERIAL EMBOLIZATION PROCEDURES INITIATED, 4 LED TO RUPTURE DURING FOLLOW-UP. CONCLUSIONS: EAST ASIAN T2EL HAD A STRONG RELATIONSHIP WITH NON-SMOKER STATUS. ALSO, T2EL WAS A SIGNIFICANT RISK FACTOR FOR SAC EXPANSION, WHICH SOMETIMES LED TO RUPTURE EVEN AFTER INTERVENTION. ALONG WITH THE HIGH PREVALENCE OF T2EL OBSERVED, EAST ASIAN T2EL MAY NOT ALWAYS BE BENIGN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154640 ENDURANT STENT GRAFT SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 00080 YR