BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE

    MDR report key: 11572694 · Received March 25, 2021

    Report

    Report Number
    2017233-2021-01814
    Event Type
    Injury
    Date Received
    March 25, 2021
    Date of Event
    January 18, 2021
    Report Date
    October 6, 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

    A REVIEW OF THE MANUFACTURING RECORDS, INCLUDING MANUFACTURING, HEPARIN COATINGS, AND STERILIZATION, INDICATED THE DEVICE MET PRE-RELEASE SPECIFICATIONS. SECTION H6: INVESTIGATION FINDINGS: WAS UPDATED TO CODE 213 TO REFLECT THIS INFORMATION. G3 CORRECTED TO "YES" FOR COMBINATION PRODUCT.

    Additional Manufacturer Narrative · 0

    G4: PMA/510K NUMBER FIELD CORRECTED FROM P040037 TO P130006.

    Additional Manufacturer Narrative · 1

    ADDITIONAL MANUFACTURER NARRATIVE: 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

    ON (B)(6) , 2021, THIS PATIENT UNDERWENT ENDOVASCULAR PROCEDURE TO TREAT A VENOUS ANASTOMOSIS STENOSIS OF AN ARTERIOVENOUS GRAFT LOCATED IN THE BASILIC VEIN IN THE RIGHT UPPER ARM USING A GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) , 2021, IT WAS OBSERVED THAT THE ENDOPROSTHESIS WAS OCCLUDED WITH THROMBUS. ON (B)(6) , 2021, A RE-INTERVENTION WAS PERFORMED TO TREAT THE OCCLUDED ENDOPROSTHESIS. BALLOON DILATATION AND THROMBOLYSIS WERE REPORTEDLY PERFORMED. THE EVENT WAS RESOLVED, AND THE PATIENT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    468583 GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE SYSTEM, ENDO GRAFT, ARTERIOVENOUS DIALYSIS ACCESS CIRCUIT STENOSIS TREATMENT PFV W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Hospitalization| O| R