BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE

    MDR report key: 18017045 · Received October 26, 2023

    Report

    Report Number
    2017233-2023-04360
    Event Type
    Injury
    Date Received
    October 26, 2023
    Date of Event
    October 6, 2023
    Report Date
    October 27, 2023
    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
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A1: NO PATIENT SPECIFIC DETAILS HAVE BEEN PROVIDED. THEREFORE, THE PATIENT INITIALS REFLECT THE W. L. GORE INTERNAL CASE NUMBER. C1: HEPARIN SURFACE INCORPORATES CARMEDA HEPARIN MANUFACTURED FROM HEPARIN SODIUM API, WHICH IS COVALENTLY BOUND TO THE DEVICE SURFACE AND IS ESSENTIALLY NON-ELUTING. H3: CODE "OTHER" WAS SELECTED AS THE MEDICAL DEVICE WAS NOT AVAILABLE FOR EVALUATION. 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. LITERATURE TITLE: OUTCOMES OF VIABAHN STENT GRAFT AT OUR HOSPITAL, SOURCE: JOURNAL OF JAPANESE SOCIETY FOR DIALYSIS THERAPY 2023: 56(SUPPL.1) P.742¿P-3-019¿ 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 PUBLICATION WAS REVIEWED, TITLE: OUTCOMES OF VIABAHN STENT GRAFT AT OUR HOSPITAL SOURCE: JOURNAL OF JAPANESE SOCIETY FOR DIALYSIS THERAPY 2023: 56(SUPPL.1) P.742¿P-3-019¿ THIS REPORT INCLUDES 4 CASES OF IMPLANTATION OF GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE IN ONE HOSPITAL FROM (B)(6) 2022. THREE MALE AND ONE FEMALE PATIENTS WERE IMPLANTED VIABAHN STENT GRAFTS IN THE LESIONS INCLUDING THE VENOUS ANASTOMOSIS OF THE ARTERIO-VENOUS GRAFT (AVG) IN THE FOREARM LOOP. THE SIZE OF IMPLANTED VIABAHN STENT GRAFTS WERE 6MM*10CM, 7MM*5CM, AND 6MM*5CM. ALL FOUR PATIENTS HAD EXPERIENCED FREQUENT OCCLUSIONS AND REQUIRED SHORT TERM PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BEFORE IMPLANTATION OF THE VIABAHN. THREE OF THE FOUR PATIENTS REMAINED PATENT AFTER THE IMPLANTATION OF THE VIABAHN, WHILE 1 PATIENT HAD AN OCCLUSION 1 MONTH AFTER IMPLANTATION. SOME OF THE THREE PATENCY CASES REQUIRED PTA, BUT THE INTERVAL OF PTAS WAS EXTENDED THAN THAT OF BEFORE THE IMPLANTATION. THIS REPORT CONCLUDES THAT THE USE OF VIABAHN CAN IMPROVE TO PROLONG THE AVG PATENCY PERIOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1691074 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 Unknown Other