BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE

    MDR report key: 23107024 · Received September 22, 2025

    Report

    Report Number
    2017233-2025-06629
    Event Type
    Malfunction
    Date Received
    September 22, 2025
    Date of Event
    September 3, 2025
    Report Date
    December 3, 2025
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    PFV
    PMA / PMN Number
    P130006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    EMDR SECTION H6, CODES C19, D15 AND D0301 UPDATED TO REFLECT RESULTS OF INVESTIGATION AND PRODUCT EVALUATION. EVALUATION SUMMARY: THE ENGINEERING EVALUATION CONFIRMED THAT THE REPORTED DISTAL TIP SEPARATION WAS CONSISTENT WITH THE CONDITION OBSERVED ON THE RETURNED DEVICE. THE APPEARANCE OF THE DISTAL SHAFT, INCLUDING THE ABSENCE OF DISTURBED PEBAX MATERIAL, INDICATES THAT THE DISTAL TIP WAS NOT BONDED TO THE SHAFT AT THE TIME OF MANUFACTURE. BASED ON THE MANUFACTURING RECORDS, THE DEVICE WAS PRODUCED DURING A PERIOD IN WHICH SOME BONDING EQUIPMENT EXPERIENCED INTERMITTENT FAILURE TO COMPLETE THE BONDING PROCESS. THEREFORE, THE MOST PROBABLE CAUSE OF THE REPORTED EVENT IS A MANUFACTURING DEFICIENCY RESULTING IN INCOMPLETE BONDING OF THE DISTAL TIP.

    Additional Manufacturer Narrative · 0

    H6: A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE VERIFIED THAT THE LOT MET ALL PRE-RELEASE SPECIFICATIONS. HEPARIN SURFACE INCORPORATES CARMEDA HEPARIN MANUFACTURED FROM HEPARIN SODIUM API, WHICH IS COVALENTLY BOUND TO THE DEVICE SURFACE AND IS ESSENTIALLY NON-ELUTING. 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 INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2025 A PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A STENOSIS OF THE RIGHT RADIAL VEIN ANASTOMOSIS OF A VASCULAR GRAFT USING GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (VSX DEVICE). AFTER THE STENT GRAFT WAS EXPANDED, A DISTAL TIP WAS SEPARATED FROM THE DELIVERY CATHETER. THE SEPARATED DISTAL TIP WAS REMOVED USING A BALLOON THROUGH A SHEATH. NO CLINICAL SEQUELA WAS REPORTED. THE PATIENT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2069755 GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE SYSTEM, ENDOVASCULAR GRAFT, ARTERIOVENOUS (AV) DIALYSIS ACCESS CIRCUIT STENOSIS PFV W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Male Required Intervention