BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE VIABAHN ENDOPROSTHESIS

    MDR report key: 10479662 · Received September 1, 2020

    Report

    Report Number
    2017233-2020-01197
    Event Type
    Injury
    Date Received
    September 1, 2020
    Date of Event
    September 18, 2018
    Report Date
    September 1, 2020
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    NIP
    PMA / PMN Number
    P040037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CBAS® HEPARIN SURFACE INCORPORATES CBAS-HEPARIN MANUFACTURED FROM HEPARIN SODIUM API, WHICH IS COVALENTLY BOUND TO THE DEVICE SURFACE AND IS ESSENTIALLY NON-ELUTING.

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS REPORTED TO GORE: IN AN ARTICLE TITLED EVOLUTION FROM PHYSICIAN-MODIFIED TO COMPANY-MANUFACTURED FENESTRATED-BRANCHED ENDOGRAFTS TO TREAT PARARENAL AND THORACOABDOMINAL AORTIC ANEURYSMS IT STATES 316 CONSECUTIVE PATIENTS (242 MALE PATIENTS; MEAN AGE, 75 YEARS) UNDERWENT F-BEVAR BETWEEN 2007 AND 2016. F-BEVAR WAS PERFORMED UNDER TWO PROSPECTIVE INVESTIGATIONAL DEVICE EXEMPTION PROTOCOLS SINCE 2013. END POINTS WERE MORTALITY, MAJOR ADVERSE EVENTS (MAES), PATIENT SURVIVAL, REINTERVENTION, BRANCH INSTABILITY, ANEURYSM-RELATED MORTALITY, RENAL FUNCTION DETERIORATION, AND TARGET VESSEL PATENCY. GORE® VIABAHN® ENDOPROSTHESES WERE UTILIZED IN THE RENAL ARTERIES. TARGET VESSEL PATENCY INCLUDED THE FOLLOWING INFORMATION: PRIMARY AND SECONDARY TARGET VESSEL PATENCY IN THE PMEG AND CMD GROUPS FOR RENAL ARTERIES WAS (97% ± 1% AND 99% ± 0.4% VS 95% ± 2% AND 98% ± 1%). FOR VESSELS TARGETED BY FENESTRATIONS VS DIRECTIONAL BRANCHES, THERE WAS NO DIFFERENCE IN 1- AND 3-YEAR PRIMARY PATENCY (96% ± 1% AND 93% ± 1% VS 96% ± 2% AND 96% ± 2%; P = .7) AND SECONDARY PATENCY (99% ±.4% AND 98% ± 1% VS 97%±2% AND 97%±2%;P = .32), RESPECTIVELY. FOR RENAL ARTERY TARGETS, PRIMARY PATENCY WAS 96% ± 1% AND 92% ± 2% FOR FENESTRATIONS VS 87% ± 6% AND 87% ± 6% FOR DIRECTIONAL BRANCHES AT THE SAME INTERVALS (P = .13). SECONDARY PATENCY WAS HIGHER FOR FENESTRATIONS (99% ± 1% AND 97% ± 1%) THAN FOR DIRECTIONAL BRANCHES (92% ± 5% AND 92% ± 5%) AT THE SAME INTERVALS, RESPECTIVELY (P = .015). LITERATURE CITATION: ODERICH GS, RIBEIRO MS, SANDRI GA, ET AL. EVOLUTION FROM PHYSICIAN-MODIFIED TO COMPANY-MANUFACTURED FENESTRATED-BRANCHED ENDOGRAFTS TO TREAT PARARENAL AND THORACOABDOMINAL AORTIC ANEURYSMS. JOURNAL OF VASCULAR SURGERY 2019;70(1):31-42.E7.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    943283 GORE VIABAHN ENDOPROSTHESIS STENT, SUPERFICIAL FEMORAL ARTERY NIP W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other| R