BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE VIABAHN ENDOPROSTHESIS - 3

    MDR report key: 8968280 · Received September 6, 2019

    Report

    Report Number
    2017233-2019-00808
    Event Type
    Injury
    Date Received
    September 6, 2019
    Date of Event
    January 1, 2019
    Report Date
    September 23, 2019
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    PFV
    PMA / PMN Number
    P040037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE LITERATURE WAS ATTACHED TO THE MEDWATCH REPORT. - ATTACHMENT: [41904_LITERATURE_21AUG2019.PDF].

    Additional Manufacturer Narrative · 0

    D5 WAS UPDATED.

    Description of Event or Problem · 1

    THIS INFORMATION WAS RECEIVED THROUGH "JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY,VOL.73,NO.15,SUPPL S.2019". THE TITLE IS "GORE® VIABAHN® STENT GRAFT FOR TREATMENT OF FREQUENTLY THROMBOSED HEMODIALYSIS VASCULAR ACCESS". THE AUTHOR:YU-CHENG HSU, MENG-HUAN LEI. BACKGROUND: THE HEMODIALYSIS VASCULAR ACCESS THROMBOSIS IS ONE OF THE MAJOR PROBLEMS IN UREMIC PATIENTS. THE PURPOSE OF THIS STUDY WAS TO EVALUATE THE EFFECT OF A VIABAHN STENT GRAFT IN THE MANAGEMENT FOR FREQUENTLY THROMBOSED HEMODIALYSIS VASCULAR ACCESS. METHODS: FROM MAY. 2014 TO OCTOBER 2018, 57 PATIENTS (29 MEN AND 28 WOMEN, AGE 36-85, MEAN AGE 63) WHO HAD FREQUENT RECURRENT TOTAL OCCLUSION OF HEMODIALYSIS VASCULAR ACCESS (MORE THAN 2 TIMES TOTAL OCCLUSION WITHIN 3 MONTHS FOLLOW-UP) WERE SENT TO OUR CATH LAB FOR RECANALIZATION AND VIABAHN STENT GRAFT IMPLANTATION. CROSS BALLOON TECHNIQUE WAS PERFORMED FIRST IN ALL PATIENTS. (RETROGRADE PUNCTURE OF THE VENOUS ROUTE WITH THE PLACEMENT OF THE PTA BALLOON IN THE AV JUNCTION; ANTEGRADE PUNCTURE WITH PLACEMENT OF ANOTHER BALLOON IN THE VENOUS RETURN NEAR THE CENTRAL VEIN). SUBSEQUENTLY,3000U HEPARIN AND 100KU UROKINASE WERE INJECTED DIRECTLY INTO THE THROMBOSED ACCESS NEAR AV JUNCTION. FOLLOWED ANGIOPLASTY WAS ACHIEVED FROM CENTRAL VEIN TO AV JUNCTION. AFTER THE FLOW RESTORED,VIABAHN STENT GRAFTS WERE PUT TO TREAT THE RESIDUAL RECOIL OR RESTENOSIS AT THE GRAFT-VENOUS JUNCTION OF HEMODIALYSIS VASCULAR ACCESS. RESULTS: THE CLINICAL SUCCESSFUL RATE IN HEMODIALYSIS VASCULAR ACCESS THROMBOSIS PATIENTS RECEIVING UROKINASE ASSISTED PTA AND VIABAHN STENT GRAFTING WERE 100% (57/57). THE CUMULATIVE PATENCY RATES WERE 73.7% AT 1 MONTH, 71.9% AT 2 MONTHS, 62.7% AT 3MONTHS, 53.3% AT 6 MONTHS, AND 40.0% AT 12 MONTHS. 15 PATIENTS DEVELOPED EARLY FAILURE (RECURRENT HEMODIALYSIS VASCULAR ACCESS AND VIABAHN STENT GRAFT THROMBOSIS) WITHIN 1 MONTH AFTER THE PROCEDURE (OCCURRED FROM DAY 3 TO DAY 27 -MEDIAN 7 DAYS).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    763660 GORE VIABAHN ENDOPROSTHESIS - 3 NIP PFV W.L. GORE & ASSOCIATES

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention