BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPLETE SE ILIAC

    MDR report key: 6352778 · Received February 23, 2017

    Report

    Report Number
    9612164-2017-00209
    Event Type
    Injury
    Date Received
    February 23, 2017
    Date of Event
    March 9, 2016
    Report Date
    January 27, 2017
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIO
    PMA / PMN Number
    P090006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MEAN AGE = 62 YEARS, MAJORITY GENDER = 14 MEN AND 18 WOMEN, DATE OF PUBLICATION JOURNAL ARTICLE TITLE: A NOISE-OPTIMIZED VIRTUAL MONOCHROMATIC RECONSTRUCTION ALGORITHM IMPROVES STENT VISUALIZATION AND DIAGNOSTIC ACCURACY FOR DETECTION OF IN-STENT RE-STENOSIS IN LOWER EXTREMITY RUN-OFF CT ANGIOGRAPHY. STEFANIE MANGOLDCARLO N. DE CECCOU. JOSEPH SCHOEPF EUR RADIOL (2016) 26:4380¿4389 DOI 10.1007/S00330-016-4304-8.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THIS RETROSPECTIVE STUDY WAS APPROVED BY THE LOCAL INSTITUTIONAL REVIEW BOARD WITH A WAIVER OF INFORMED CONSENT. WE IDENTIFIED 32 PATIENTS (14 MEN AND 18 WOMEN) WITH KNOWN PERIPHERAL ARTERY DISEASE TREATED WITH STENT PLACEMENT WHO HAD UNDERGONE LOWER EXTREMITY DE-CTA ON A THIRD GENERATION DSCT SYSTEM BETWEEN 1 MAY 2014 AND 31 JULY 2015. EXCLUSION CRITERIA WERE DEVIATIONS FROM THE STANDARD SCAN PROTOCOL AND INSUFFICIENT ARTERIAL CONTRAST ENHANCEMENT DEFINED AS AN ATTENUATION OF THE DISTAL ABDOMINAL AORTA <(><<)>150 HOUNSFIELD UNITS (HU). INFORMATION ABOUT STENT MATERIAL AND SIZE WAS AVAILABLE FOR 39/ 45 STENTS. NINE DIFFERENT STENT TYPES WERE PRESENT AND STENT MATERIAL WAS EITHER STAINLESS STEEL (ICAST STENT, ATRIUM MEDICAL CORPORATION, (B)(4), USA, N = 6; EXPRESSTM LD ILIAC, BOSTON SCIENTIFIC, (B)(4), USA, N = 6), NITINOL (COMPLETETM VASCULAR STENT SYSTEM, MEDTRONIC VASCULAR, (B)(4), USA, N = 9; PROTEGETM EVERFLEXTM SELF-EXPANDING PERIPHERAL STENT SYSTEM, COVIDIEN, (B)(4), USA, N= 5; ZENITH® SPIRAL-ZTM AAA ILIAC LEG GRAFT, COOK MEDICAL INC, (B)(4), USA, N = 2; ENDURANT II AAA STENT, MEDTRONIC VASCULAR, N = 1; SUPERA® PERIPHERAL STENT SYSTEM, ABBOTT VASCULAR, (B)(4), USA, N = 4) OR POLYTETRAFLUOROETHYLENE (PTFE; VIABAHN ENDOPROSTHESIS, GORE AND ASSOCIATES, (B)(4), USA, N =1; GORE® PROPATEN® VASCULAR GRAFT, GORE AND ASSOCIATES, N = 5). STENTS WERE PRESENT IN THE ILIAC (N= 14), FEMORAL (N= 27) AND POPLITEAL ARTERIES (N= 4). TWENTY-EIGHT STENTS IN 21 PATIENTS WERE PRESENT AT INVASIVE DSA. TWELVE STENTS SHOWED NO INTIMAL HYPERPLASIA OR RE-STENOSIS. NEOINTIMAL HYPERPLASIA CAUSING <(><<)>50 % LUMEN NARROWING WAS DETECTED IN FOUR STENTS ON DSA WHILE RESTENOSIS WITH LUMEN NARROWING =50 % WAS FOUND IN 12 STENTS. THESE PATIENTS SUBSEQUENTLY UNDERWENT THROMBOEMBOLECTOMY AND BALLOON ANGIOPLASTY (N=7), OPERATIVE ATHERECTOMY (N= 3) OR BYPASS SURGERY (N= 2). 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). METHOD: 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. KEY POINTS THE IMPACT OF NOISE-OPTIMIZED VIRTUAL MONOCHROMATIC IMAGING ON STENT VISUALIZATION WAS ASSESSED. VIRTUAL MONOCHROMATIC IMAGING SIGNIFICANTLY IMPROVES STENT LUMEN VISUALIZATION AND DIAGNOSTIC CONFIDENCE. AT 80 KEV DIAGNOSTIC PERFORMANCE FOR DETECTION OF IN-STENT RESTENOSIS WAS INCREASED. (EIGHTY) 80 KEV VIRTUAL MONOCHROMATIC IMAGES ARE RECOMMENDED FOR STENT EVALUATION OF LOWER EXTREMITY VASCULATURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135446 COMPLETE SE ILIAC STENT, ILIAC NIO MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention