BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT II

    MDR report key: 6329967 · Received February 14, 2017

    Report

    Report Number
    2953200-2017-00197
    Event Type
    Injury
    Date Received
    February 14, 2017
    Date of Event
    February 23, 2016
    Report Date
    January 25, 2017
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: SEX. 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; A NOISE-OPTIMIZED VIRTUAL MONOCHROMATIC RE CONSTRUCTION ALGORITHM IMPROVES STENT VISUALIZATION AND DIAGNOSTIC ACCURACY FOR DETECTION OF IN-STENT RE-STENOSIS IN LOWER EXTREMITY RUN-OFF CT ANGIOGRAPHY. STEFANIE MANGOLD <(>&<)> CARLO N. DE CECCO1 <(>&<)> U. JOSEPH SCHOEPF <(>&<)> RICARDO T. YAMADA1 <(>&<)> AKOS VARGA-SZEMES <(>&<)> ANDREW C. STUBENRAUCH <(>&<)> DAMIANO CARUSO <(>&<)> STEPHEN R. FULLER <(>&<)> THOMAS J. VOGL <(>&<)> KONSTANTIN NIKOLAOU <(>&<)> THOMAS M. TODORAN <(>&<)> JULIAN L. WICHMANN. EUR RADIOL (2016) 26:4380¿4389. DOI 10.1007/S00330-016-4304-8 AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. THE FOLLOWING INFORMATION IS IN THIS JOURNAL ARTICLE: STENT GRAFT OCCLUSION. ABSTRACT PURPOSE TO EVALUATE THE IMPACT OF NOISE-OPTIMIZED VIRTUAL MONOCHROMATIC IMAGING (VMI+) ON STENT VISUALIZATION AND ACCURACY FOR IN-STENT RE-STENOSIS AT LOWER EXTREMITY DUAL ENERGY CT ANGIOGRAPHY (DE-CTA). MATERIAL AND METHODS WE EVALUATED THIRD-GENERATION DUAL SOURCE DE-CTA STUDIES IN 31 PATIENTS WITH PRIOR STENT PLACEMENT. IMAGES WERE RECONSTRUCTED WITH LINEAR BLENDING (F_0.5) AND VMI+ AT 40¿150 KEV. IN-STENT LUMINAL DIAMETER WAS MEASURED AND CONTRAST-TO-NOISE RATIO (CNR) CALCULATED. DIAGNOSTIC CONFIDENCE WAS DETERMINED USING A FIVE-POINT SCALE. IN 21 PATIENTS WITH INVASIVE CATHETER ANGIOGRAPHY, ACCURACY FOR SIGNIFICANT RE-STENOSIS (=50 %) WAS ASSESSED AT F_0.5 AND 80 KEV-VMI+ CHOSEN AS THE OPTIMAL ENERGY LEVEL BASED ON IMAGE-QUALITY ANALYSIS. RESULTS AT CTA, 45 STENTS WERE PRESENT. DSA WAS AVAILABLE FOR 28 STENTS WHEREAS 12 STENTS SHOWED SIGNIFICANT RE-STENOSIS. CNR WAS SIGNIFICANTLY HIGHER WITH =80 KEV-VMI+ (17.9 ± 6.4¿33.7 ± 12.3) COMPARED TO F_0.5 (16.9 ± 4.8; ALL P <(><<)> 0.0463); LUMINAL STENT DIAMETERS WERE INCREASED AT =70 KEV (5.41 ± 1.8¿5.92 ± 1.7 VS. 5.27 ± 1.8, ALL P <(> <<)> 0.001) AND DIAGNOSTIC CONFIDENCE WAS HIGHEST AT 70¿80 KEV-VMI+ (4.90 ± 0.48¿4.88 ± 0.63 VS. 4.60 ± 0.66, P = 0.001, 0.0042). SENSITIVITY, NEGATIVE PREDICTIVE VALUE AND ACCURACY FOR RESTENOSIS WERE HIGHER WITH 80 KEV-VMI+ (100, 100, 96.4 %) THAN F_0.5 (90.9, 94.1, 89.3 %). CONCLUSION 80 KEV-VMI+ IMPROVES IMAGE QUALITY, DIAGNOSTIC CONFIDENCE AND ACCURACY FOR STENT EVALUATION AT LOWER EXTREMITY DE-CTA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    111930 ENDURANT II SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention