BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE VIABAHN ENDOPROSTHESIS WITH PROPATEN BIOACTIVE SURFACE

    MDR report key: 10613181 · Received October 1, 2020

    Report

    Report Number
    2017233-2020-01316
    Event Type
    Injury
    Date Received
    October 1, 2020
    Date of Event
    August 13, 2020
    Report Date
    October 8, 2021
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    PFV
    PMA / PMN Number
    P130006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING WAS CORRECTED: SECTION G4 (PMA/510(K)NUMBER) CORRECTED TO P130006.

    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 WAS REPORTED TO GORE: ON (B)(6) 2020, THE PATIENT WITH DIABETIC NEPHROPATHY UNDERWENT ENDOVASCULAR PROCEDURE TO TREAT VENOUS ANASTOMOSIS STENOSIS OF AN UPPER ARM LOOP ARTERIOVENOUS GRAFT IN THE RIGHT BASILIC VEIN USING A GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE. REPORTEDLY, ARTERIAL ANASTOMOSIS STENOSIS IN THE BRACHIAL ARTERY WAS ALSO TREATED AT THE SAME TIME. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2020, THE PATIENT PRESENTED WITH OCCLUSION OF THE VASCULAR ACCESS. SURGICAL THROMBECTOMY WAS PERFORMED, AND ANGIOGRAPHY THEN REVEALED THAT THERE WAS RESTENOSIS OF THE ARTERIAL ANASTOMOSIS AND STENOSIS AT THE PROXIMAL END OF THE ENDOPROSTHESIS. THEREFORE, BALLOONING WAS PERFORMED. REPORTEDLY, SURPLUS PORTION OF THE ARTERIOVENOUS GRAFT WAS RESECTED AND RE-ANASTOMOSED AT THE SAME TIME. THE OCCLUSION WAS IMPROVED, AND THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2020, THE PATIENT PRESENTED AGAIN WITH OCCLUSION OF THE VASCULAR ACCESS. RESTENOSIS OF THE ARTERIAL ANASTOMOSIS AND STENOSIS AT THE PROXIMAL END OF THE ENDOPROSTHESIS WERE ALSO CONFIRMED. THE EVENT WAS REPORTEDLY CONSIDERED RELATED TO THE ENDOPROSTHESIS. SURGICAL THROMBECTOMY AND BALLOONING WERE PERFORMED, HOWEVER, SIGNIFICANT RECOIL WAS OBSERVED AT THE PROXIMAL END OF THE ENDOPROSTHESIS, AND AN ADDITIONAL GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE WAS IMPLANTED. THE OCCLUSION WAS RESOLVED, AND THE PATIENT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1082560 GORE VIABAHN ENDOPROSTHESIS WITH PROPATEN BIOACTIVE SURFACE SYSTEM, ENDO GRAFT, ARTERIOVENOUS DIALYSIS ACCESS CIRCUIT STENOSIS TREATMENT PFV W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention