BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE

    MDR report key: 21923828 · Received April 29, 2025

    Report

    Report Number
    2017233-2025-06118
    Event Type
    Malfunction
    Date Received
    April 29, 2025
    Date of Event
    April 15, 2025
    Report Date
    June 6, 2025
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    NIP
    UDI-DI
    00733132624829
    PMA / PMN Number
    P040037
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    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. 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.

    Additional Manufacturer Narrative · 0

    C19 - THE MANUFACTURING RECORDS WERE REVIEWED AND DOCUMENTED IN THE PRODUCT HISTORY TASK. THE DEVICE LOT MET ALL PRE-RELEASE SPECIFICATIONS. THE PRIMARY REPORTED FAILURE MODE, RELATED TO PARTIAL DEPLOYMENT DUE TO A STUCK DEPLOYMENT LINE, COULD NOT BE CONFIRMED DURING ENGINEERING EVALUATION. HOWEVER, THE ENGINEERING EVALUATION DID OBSERVE DAMAGE CONSISTENT WITH DEPLOYMENT DIFFICULTY (E.G. BROKEN DEPLOYMENT LINE FIBERS, SHIFTED AND BUNCHED OUTER AND INNER ZIPPERS). 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 OR WITHIN THE CATHETER DUAL LUMEN. THE INVESTIGATION COULD NOT CONFIRM THE CAUSE OF THE REPORTED HAZARDOUS SITUATION NOR THE PRIMARY DEVICE FAILURE MODE. THE RETURNED DEVICE EXHIBITED SEVERAL FORMS OF DAMAGE (E.G. FLOWERED ENDOPROSTHESIS STRUT ROW; EXPOSED APICES; EXPOSED DISTAL SHAFT; SHIFTED, COMPRESSED, AND TWISTED ENDOPROSTHESIS). THE CAUSE FOR THESE DAMAGES COULD NOT BE DETERMINED, BUT THEY ARE CONSISTENT WITH DAMAGE RESULTING FROM THE INABILITY TO DEPLOY AFTER MULTIPLE ATTEMPTS, AN UNKNOWN DEVICE INTERACTION DURING WITHDRAWAL, OR MANIPULATION OF THE DEVICE EITHER DURING OR AFTER THE PROCEDURE.

    Description of Event or Problem · 0

    IT WAS REPORTED TO GORE THAT ON (B)(6), 2025, A PATIENT WAS TO BE IMPLANTED WITH 13MM X 5CM GORE® VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (VSX DEVICE) TO TREAT RIGHT COMMON ILIAC ARTERY STENOSIS AND OCCLUSION. PRE-DILATION WAS PERFORMED WITH EV3 BALLOON. THE VSX DEVICE WAS ADVANCED TO TARGET LESION VIA AMPLATZ GUIDEWIRE AND 12 FR SHEATH. WHEN PULLING OUT DEPLOYMENT LINE, IT GOT STUCK. IT COULDN'T BE DEPLOYED AFTER MULTIPLE ATTEMPTS. AFTER REMOVAL, IT WAS FOUND THE DEPLOYMENT LINE LOOSEN. ANOTHER VSX DEVICE WITH SAME SIZE WAS UTILIZED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    481928 GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE STENT, SUPERFICIAL FEMORAL ARTERY NIP W. L. GORE & ASSOCIATES, INC. 00733132624829

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Male