BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE

    MDR report key: 11959849 · Received June 8, 2021

    Report

    Report Number
    2017233-2021-02065
    Event Type
    Injury
    Date Received
    June 8, 2021
    Date of Event
    December 1, 2020
    Report Date
    June 8, 2021
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    NIP
    PMA / PMN Number
    P040037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ¿FOUR CASES THAT WAS TREATED OF POSTOPERATIVE BLEEDING DUE TO PANCREATIC FISTULA USING VIABAHN STENT¿ (NOBUYASU SUZUKI, ET.AL., GENERAL MEETING OF THE JAPANESE SOCIETY OF GASTROENTEROLOGY SURGERY, 2020(75), P313-4 ). 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 LITERATURE WAS REVIEWED ¿FOUR CASES THAT WAS TREATED OF POSTOPERATIVE BLEEDING DUE TO PANCREATIC FISTULA USING VIABAHN STENT¿ (NOBUYASU SUZUKI, ET.AL., GENERAL MEETING OF THE JAPANESE SOCIETY OF GASTROENTEROLOGY SURGERY, 2020(75), P313-4 ). CASE 1: A (B)(6) MALE UNDERWENT PYLORUS-PRESERVING PANCREATODUODENECTOMY TO TREAT A PANCREATIC HEAD CANCER. A PANCREATIC FISTULA WAS OBSERVED POSTOPERATIVELY, AND HEMORRHAGE FROM THE COMMON HEPATIC ARTERY ANEURYSM WAS OBSERVED ON THE 17TH POSTOPERATIVE DAY. A GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE WAS SUCCESSFULLY PLACED TO TREAT THE BLEEDING. AT AN UNKNOWN TIME AFTER THE PROCEDURE, STENT GRAFT OCCLUSION WAS CONFIRMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    858256 GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE STENT, SUPERFICIAL FEMORAL ARTERY NIP W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization