BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE

    MDR report key: 13929768 · Received March 28, 2022

    Report

    Report Number
    2017233-2022-02830
    Event Type
    Injury
    Date Received
    March 28, 2022
    Date of Event
    November 1, 2021
    Report Date
    March 28, 2022
    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
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DUE TO AN UNKNOWN LOT/SERIAL NUMBER AND NO DEVICE RETURN, AN INVESTIGATION COULD NOT BE PERFORMED. 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 · 0

    THE FOLLOWING LITERATURE WAS REVIEWED: DAIHIKO EGUCHI AND KEIJI YOSHIYA. EXPERIENCE WITH VIABAHN USE AT OUR HOSPITAL: A HUNDRED CASES FROM AUGUST 2017 THROUGH OCTOBER 5, 2020. KIDNEY AND DIALYSIS. 2021; 91 (A SEPARATE VOLUME ACCESS 2021): 180-181. INTRODUCTION IN THIS ARTICLE, WE SUMMARIZE OUR EXPERIENCE WITH USE OF GORE® VIABAHN® ENDOPROSTHESIS, PRESENT CASE EXAMPLES AND DISCUSS THE KNACKS AND PITFALLS OF ITS USE IN THE VASCULAR ACCESS INTERVENTION THERAPY (VAIVT) FIELD. DETAILS OF THE CASES VIABAHN WAS USED FOR VASCULAR INJURY FOR 32 CASES AND OTHER INDICATIONS FOR 68 CASES. VIABAHN WAS PLACED FOR ARTERIOVENOUS GRAFT IN 71 CASES AND FOR ARTERIOVENOUS FISTULA IN 29 CASES. TROUBLES DURING PROCEDURE AND POSTOPERATIVE COMPLICATIONS. TROUBLES DURING PROCEDURE A SHAFT BREAKAGE DURING INSERTION OF THE CATHETER: THE CATHETER WAS GRASPED NEAR THE TIP AND INSERTED WITH SHORT STROKES. A CATHETER UNABLE TO ADVANCE: IT WAS RESOLVED BY USING A LONG SHEATH. A BOWSTRING PHENOMENON: IT WAS RESOLVED BY USING A STIFFER GUIDEWIRE. POSTOPERATIVE COMPLICATIONS EARLY RESTENOSIS: IT MIGHT HAVE BEEN DUE TO DEVICE SIZE MISMATCH. STENT GRAFT STENOSIS: IT WAS DUE TO FIBRIN MEMBRANE DEPOSITED INSIDE THE STENT GRAFT INFECTION (3.5 MONTHS AFTER THE PROCEDURE): THE DEVICE WAS EXTRACTED SURGICALLY. MIGRATION: IT OCCURRED IN A CASE OF VIABAHN PLACEMENT IN THE CEPHALIC ARCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    879821 GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE STENT, SUPERFICIAL FEMORAL ARTERY NIP W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization| R| O