BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE

    MDR report key: 12346263 · Received August 19, 2021

    Report

    Report Number
    2017233-2021-02290
    Event Type
    Injury
    Date Received
    August 19, 2021
    Date of Event
    August 7, 2020
    Report Date
    August 20, 2021
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    NIP
    PMA / PMN Number
    P040037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IMPLANT DATE WAS UNAVAILABLE. PATIENT DEMOGRAPHICS: PROVIDED MEAN AGE WAS 70.48¿9.02 YEARS OLD, AND GENDER OF ARTICLE IS N=25 MALE, N=6 FEMALE, WEIGHT IS 71.23¿12.88 KG. PATIENT INFORMATION WILL REFLECT 70-YEAR-OLD MALE WITH 71KG. ARTICLE CITATION: INTERNAL ILIAC ARTERY PRESERVATION OUTCOMES OF¿ENDOVASCULAR AORTIC REPAIR FOR¿COMMON ILIAC ANEURYSM: ILIAC BRANCH DEVICE VERSUS¿CROSSOVER CHIMNEY TECHNIQUE YA-TING¿GU, ET AL. HTTPS://DOI.ORG/10.1007/S00380-020-01678-X PUBLISHED ONLINE: 7 AUGUST 2020 HEART AND VESSELS (2021) 36:235241 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 RECEIVED THROUGH LITERATURE INTERNAL ILIAC ARTERY PRESERVATION OUTCOMES OF¿ENDOVASCULAR AORTIC REPAIR FOR¿COMMON ILIAC ANEURYSM: ILIAC BRANCH DEVICE VERSUS¿CROSSOVER CHIMNEY TECHNIQUE PUBLISHED IN HEART AND VESSELS. THE STUDY AIMED TO COMPARE THE OUTCOMES OF USING ILIAC BRANCH DEVICES (30 PATIENTS, NON-GORE DEVICES) AND THE CROSSOVER CHIMNEY (31 PATIENTS, VIABAHN DEVICES) TECHNIQUE FOR PRESERVING THE INTERNAL ILIAC ARTERY DURING ENDOVASCULAR AORTIC REPAIR IN 61 PATIENTS WITH COMMON ILIAC ANEURYSM FROM FEBRUARY 2010 TO JULY 2016. 2 PATIENTS EXHIBITED TYPE 1A ENDOLEAK, SUCCESSFULLY TREATED THROUGH REPEATED BALLOONING REINTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1243075 GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE STENT, SUPERFICIAL FEMORAL ARTERY NIP W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention