BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE

    MDR report key: 24623957 · Received March 17, 2026

    Report

    Report Number
    2017233-2026-07261
    Event Type
    Malfunction
    Date Received
    March 17, 2026
    Date of Event
    February 25, 2026
    Report Date
    April 7, 2026
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    NIP
    UDI-DI
    00733132653560
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CBAS® HEPARIN SURFACE INCORPORATES CARMEDA HEPARIN MANUFACTURED FROM HEPARIN SODIUM API, WHICH IS COVALENTLY BOUND TO THE DEVICE SURFACE AND IS ESSENTIALLY NON-ELUTING. H6 - CODE C19: A REVIEW OF MANUFACTURING RECORDS VERIFIED THAT THE LOT INVOLVED IN THIS COMPLAINT MET ALL PRE-RELEASE SPECIFICATIONS. H6 - CODE C21: THE SPECIMEN WAS RETURNED ON (B)(6) 2026. RESULTS PENDING COMPLETION OF INVESTIGATION. 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 HAVE NOT 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.

    Additional Manufacturer Narrative · 0

    ENGINEERING EVALUATION RESULTS: IT WAS REPORTED THAT A VIABAHN® DEVICE ENCOUNTERED A STUCK DEPLOYMENT LINE AND BOWSTRINGING OF THE ENDOPROSTHESIS AFTER PARTIAL DEPLOYMENT. PARTIAL DEPLOYMENT OF THE VIABAHN® DEVICE WITH PARTIAL EXPANSION AT THE DISTAL END OF THE ENDOPROSTHESIS WAS CONFIRMED BOTH BY IMAGES/VIDEO PROVIDED AND BY THE CONDITION OF THE DEVICE AS RETURNED FOR EVALUATION. THE REPORT OF A STUCK DEPLOYMENT LINE AND BOWSTRINGING COULD NOT BE DIRECTLY CONFIRMED. DEPLOYMENT OF THE RETURNED VIABAHN® DEVICE WAS ABLE TO CONTINUE DURING EVALUATION WHEN PULLING THE DEPLOYMENT LINE AT THE ENDOPROSTHESIS, DEMONSTRATING THAT THE DEPLOYMENT MECHANISM ITSELF WAS NOT STUCK. PROCEDURAL AND BENCHTOP DEPLOYMENT OF THE DEVICE CAN BE IMPACTED BY DIFFERENT FACTORS INCLUDING BUT NOT LIMITED TO ZIPPER INTEGRITY, DELIVERY SYSTEM SUPPORT OR STIFFNESS, OR PRESENCE OF DRIED FLUID ON THE DEVICE. THE INVESTIGATION COULD NOT CONFIRM THE CAUSE OF THE REPORTED HAZARDOUS SITUATION NOR ASSIGN A PRIMARY DEVICE FAILURE MODE.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO GORE: THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2026, DURING TREATMENT OF A SUPERIOR MESENTERIC ARTERY (SMA) ANEURYSM, THE SMA WAS CATHETERIZED WITH AN 0.035 X 300 AMPLATZ GUIDEWIRE INSIDE A LONG 8 X 90 COOK SHEATH POSITIONED AT ITS ORIGIN. THE 8MM X 10CM GORE® VIABAHN® ENDOPROSTHESIS WITH PROPATEN BIOACTIVE SURFACE (VIABAHN® DEVICE) WAS POSITIONED CLOSE TO THE ORIGIN OF THE SMA WITH ITS DISTAL TIP JUST BEFORE THE LARGE SMA BRANCH. IT WAS REPORTED THAT UNDER FLUOROSCOPIC GUIDANCE, THE VIABAHN® DEVICE DEPLOYMENT KNOB WAS PULLED APPROXIMATELY 15 CM. THE VIABAHN® STENT DID NOT RELEASE, BUT THE DISTAL TIP WAS PULLED, MOBILIZING THE SMA TOWARD THE AORTA. FURTHER ATTEMPTS AT DEPLOYMENT SHOWED THE VIABAHN® DEVICE EXHIBITING THE SAME BEHAVIOR. IT WAS DECIDED TO ABORT THE RELEASE ATTEMPT; THE SHEATH WAS ADVANCED OVER THE VIABAHN® DEVICE DELIVERY SYSTEM AND DEVICES WERE REMOVED FROM THE PATIENT. THERE WAS NO VASCULAR INJURY, AND THE PATIENT WAS DOING WELL. AS REPORTED, THE DEPLOYMENT LINE UNRAVELED TO THE DISTAL TIP, BUT THE VIABAHN® DEVICE DID NOT START EXPANDING. THE PHYSICIAN STATED THE ISSUE MAY HAVE BEEN WHERE THE DEVICE RELEASES AT THE DISTAL TIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450702 GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE STENT, SUPERFICIAL FEMORAL ARTERY NIP W. L. GORE & ASSOCIATES, INC. 00733132653560

    Patients

    Seq Age Sex Outcome Treatment
    1