BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE

    MDR report key: 24265566 · Received February 5, 2026

    Report

    Report Number
    2017233-2026-07116
    Event Type
    Malfunction
    Date Received
    February 5, 2026
    Date of Event
    January 24, 2026
    Report Date
    March 12, 2026
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    NIP
    UDI-DI
    00733132647408
    PMA / PMN Number
    P040037
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATE D9: DATE DEVICE RETURNED TO MANUFACTURER. UPDATE H6: CODE C19 - THE MANUFACTURING RECORDS WERE REVIEWED, THE DEVICE LOT MET ALL PRE-RELEASE SPECIFICATIONS. CODE D15 - THE PRIMARY REPORTED FAILURE MODE OF PARTIAL DEPLOYMENT WITH DEPLOYMENT LINE STUCK COULD NOT BE CONFIRMED BY THE ENGINEERING EVALUATION OR REPORTED INFORMATION. THREE NON-CLINICAL DEVICE PHOTOS WERE SUBMITTED FOR REVIEW WHICH DEMONSTRATES A VIABAHN DEVICE WITH BLOOD STAINING ON THE DEVICE SUGGESTING PATIENT CONTACT. THE DEPLOYMENT KNOB IS DETACHED FROM THE HUB AND THE ENDO IS FULLY CONSTRAINED, ALIGNING WITH THE REPORTED PARTIAL DEPLOYMENT AND REFLECTS THE AS-RECEIVED STATE OF THE VIABAHN DEVICE EVALUATED BY ENGINEERS. THE ENGINEERS OBSERVED THE DEVICE AS RETURNED WAS PARTIALLY DEPLOYED, THE DEPLOYMENT KNOB WAS DETACHED FROM THE HUB WITH LOOSE DEPLOYMENT LINE AT THE KNOB AND TRANSITION WITH NO EXPANSION OF THE ENDO, HOWEVER DEPLOYMENT WAS ABLE TO CONTINUE VIA THE KNOB. REPLICATION OF THIS FAILURE MODE IS NOT ALWAYS POSSIBLE BECAUSE OF DIFFERENCES BETWEEN CONDITIONS SEEN IN VIVO (I.E., PATIENT ANATOMY, PROCEDURAL CONDITIONS) AND THOSE SEEN IN THE LABORATORY. PROCEDURAL 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 OR WITHIN THE CATHETER DUAL LUMEN. THE ROOT CAUSE OF THE STUCK DEPLOYMENT LINE COULD NOT BE ESTABLISHED WITH THE AVAILABLE INFORMATION, INCLUDING DEVICE EVALUATION. THE ENGINEERS OBSERVED DAMAGE TO THE DEVICE. THE DISTAL SHAFT AND CATHETER WERE KINKED AND THE ENDO DISPLACED IN A DISTAL DIRECTION. THE CAUSE FOR THIS DAMAGE COULD NOT BE DETERMINED, BUT IT IS CONSISTENT WITH DAMAGE RESULTING FROM THE REPORTED INABILITY TO DEPLOY, AN UNKNOWN DEVICE INTERACTION DURING WITHDRAWAL, OR MANIPULATION OF THE DEVICE EITHER DURING OR AFTER THE PROCEDURE.

    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. H6: CODE C21 - THE DEVICE WILL BE RETURNED AND WILL BE EVALUATED BY GORE. 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 A PATIENT WAS TO BE IMPLANTED WITH A GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (VIABAHN DEVICE) TO BUILD CHIMNEY AT RENAL ARTERY DURING AAA TREATMENT. PHYSICIAN DELIVERED VIABAHN DEVICE TO TARGET LESION AND PREPARED FOR DEPLOYMENT. AFTER PULLING THE DEPLOYMENT KNOB APPROXIMATELY 7 CENTIMETERS, THE PHYSICIAN FELT SIGNIFICANT RESISTANCE AND DISCOVERED THE DEPLOYMENT LINE WAS STUCK AND COULD NOT BE PULLED OUT FURTHER. VIABAHN DEVICE WAS REMOVED AND ANOTHER NEW VIABAHN DEVICE OF SAME MODEL WAS USED COMPLETE THE PROCEDURE SUCCESSFULLY. THE PATIENT DIDN'T EXPERIENCE ANY ADVERSE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    327383 GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE STENT, SUPERFICIAL FEMORAL ARTERY NIP W. L. GORE & ASSOCIATES, INC. 00733132647408

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male