BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE

    MDR report key: 18517424 · Received January 16, 2024

    Report

    Report Number
    2017233-2024-04551
    Event Type
    Injury
    Date Received
    January 16, 2024
    Date of Event
    December 18, 2023
    Report Date
    January 16, 2024
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    NIP
    PMA / PMN Number
    P040037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    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: CBAS® 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 REMAINS IMPLANTED. RETURN NOT POSSIBLE. 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

    IT WAS REPORTED TO GORE THAT THE PATIENT PRESENTED WITH AN ANEURYSM IN THE LEFT AND RIGHT COMMON ILIAC ARTERY, LEFT AND RIGHT INTERNAL ILIAC ARTERY, AS WELL AS ABDOMINAL AORTA. IT WAS STATED THAT THE PHYSICIAN INTENDED TO IMPLANT A GORE® VIABAHN® ENDOPROSTHESIS WITH PROPATEN® BIOACTIVE SURFACE INTO THE LEFT AND RIGHT INTERNAL ILIAC ARTERY TO HAVE THOSE CONNECTED TO ¿OPEN¿ GRAFTS THE NEXT DAY. IT WAS REPORTED THAT THE IMPLANTATION OF THE GORE® VIABAHN® ENDOPROSTHESIS WITHIN THE LEFT INTERNAL ILIAC ARTERY WENT SUCCESSFULLY AND WITHOUT ANY COMPLICATION. IT WAS STATED THAT THE GORE® VIABAHN® ENDOPROSTHESIS, WHICH WAS IMPLANTED WITHIN THE RIGHT INTERNAL ILIAC ARTERY, WAS PLACED, AND IMPLANTED TOO DISTALLY AND THEREFORE COVERED UNINTENTIONALLY A SIDE BRANCH BY 25-75% WHICH AFFECTED THE BLOOD FLOW. IT WAS STATED THAT THE SURGICAL TEAM HAD DIFFICULTIES TO GET A GOOD ANGIOGRAPHY TO SUPPORT ACCURATE PLACEMENT OF THE MEDICAL DEVICES AND THAT THE REASON REMAINS UNKNOWN WHY THE DEVICE WAS PLACED TOO DISTALLY. HOWEVER, THE UNINTENTIONAL COVERAGE WAS RECOGNIZED BY THE SURGEON WHO STATED THAT THE SIDE BRANCH WILL MOST LIKELY OCCLUDE RIGHT AFTER THE PROCEDURE IS COMPLETED. THEREFORE THE THROMBOSIS, WITHIN THE UNINTENTIONALLY COVERED SIDE BRANCH, WAS REMOVED IN COMBINATION WITH THE CONNECTION OF THE IMPLANTED GORE® VIABAHN® ENDOPROSTHESES WITH THE AORTIC GRAFTS THE NEXT DAY. IT WAS REPORTED TO GORE THAT THE PATIENT WAS DOING WELL AFTER THE PROCEDURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    872923 GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE STENT, SUPERFICIAL FEMORAL ARTERY NIP W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention