BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE

    MDR report key: 20380237 · Received October 6, 2024

    Report

    Report Number
    2017233-2024-05376
    Event Type
    Injury
    Date Received
    October 6, 2024
    Date of Event
    June 8, 2024
    Report Date
    October 7, 2024
    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

    HEPARIN SURFACE INCORPORATES CARMEDA HEPARIN MANUFACTURED FROM HEPARIN SODIUM API, WHICH IS COVALENTLY BOUND TO THE DEVICE SURFACE AND IS ESSENTIALLY NON-ELUTING. LITERATURE TITLE: TWO CASES OF VIABAHN SHORTENING AND MIGRATION AFTER SURGICAL THROMBECTOMY IN HEMODIALYSIS PATIENTS. SOURCE: JOURNAL OF JAPANESE SOCIETY FOR DIALYSIS THERAPY 2024:57 SUPPLEMENT 1:P.799. A1: NO PATIENT SPECIFIC DETAILS HAVE BEEN PROVIDED. THEREFORE, THE PATIENT INITIALS REFLECT THE W. L. GORE INTERNAL CASE NUMBER. H3: CODE "OTHER" WAS SELECTED AS THE MEDICAL DEVICE REMAINS IMPLANTED. RETURN NOT POSSIBLE. H3: CODE ¿OTHER¿ WAS SELECTED AS NO DEVICE INFORMATION (SERIAL OR LOT NUMBER) IS AVAILABLE AND NO DEVICE WAS RETURNED. H6: A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE COULD NOT BE PERFORMED AS A VALID LOT NUMBER WAS NOT PROVIDED. H6: CODE D12: ACCORDING TO THE GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE INSTRUCTIONS FOR USE (IFU), ADVERSE EVENTS THAT MAY OCCUR AND/OR REQUIRE INTERVENTION INCLUDE, BUT ARE NOT LIMITED TO: OCCLUSION (THROMBOSIS AND/OR STENOSIS) OF ENDOPROSTHESIS OR VESSEL. W. L. GORE & ASSOCIATES, INC. (GORE) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY GORE, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. BLANK FIELDS PRESENT ON THIS REPORT INCLUDE REQUIRED FIELDS AND FIELDS DETERMINED TO BE NOT APPLICABLE. BLANK REQUIRED FIELDS INDICATE THAT THE INFORMATION WAS NOT PROVIDED, WAS DEEMED UNAVAILABLE OR WAS NOT APPLICABLE. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, GORE, OR ITS ASSOCIATES THAT THE DEVICE, GORE OR ITS ASSOCIATES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE A LEGAL ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY DEFECTS OR HAS MALFUNCTIONED, AS DEFINED FROM A LEGAL STANDPOINT. THESE WORDS ARE INCLUDED IN THE REPORT AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT.

    Description of Event or Problem · 0

    THE FOLLOWING PUBLISHMENT WAS REVIEWED BY GORE: TITLE: TWO CASES OF VIABAHN SHORTENING AND MIGRATION AFTER SURGICAL THROMBECTOMY IN HEMODIALYSIS PATIENTS. SOURCE: JOURNAL OF JAPANESE SOCIETY FOR DIALYSIS THERAPY 2024:57 SUPPLEMENT 1:P.799. CASE 2: ON UNKNOWN DATE, A 61-YEAR-OLD MALE HEMODIALYSIS PATIENT UNDERWENT A SHUNT CREATION WITH A 6 MM DIAMETER LOOP GRAFT (UNKNOWN GRAFT). ON UNKNOWN DATE, BUT X - 46 DAYS, A PTA WAS PERFORMED FOR SHUNT FAILURE. ON UNKNOWN DATE, X, AFTER SURGICAL THROMBUS REMOVAL FOR SHUNT OCCLUSION, A 6 MM X 75 MM GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (VSX DEVICE) WAS IMPLANTED. ON UNKNOWN DATE, X + 1 DAY, SHUNT OCCLUSION OCCURRED AGAIN. ON UNKNOWN DATE, X + 4 DAYS, A SURGICAL THROMBUS REMOVAL WAS PERFORMED AND SHORTENING AND MIGRATION OF THE VSX DEVICE, POSSIBLY CAUSED BY A FOGARTY CATHETER, WAS OBSERVED. PERCUTANEOUS THROMBECTOMY IS PREFERABLE FOR EARLY SHUNT OCCLUSION AFTER VSX DEVICE IMPLANTATION, AND VSX DEVICE WITH A GRAFT DIAMETER OF +1 MM SHOULD BE IMPLANTED WHENEVER POSSIBLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2603331 GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE STENT, SUPERFICIAL FEMORAL ARTERY NIP W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male Required Intervention