BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE

    MDR report key: 23856796 · Received December 19, 2025

    Report

    Report Number
    2017233-2025-06984
    Event Type
    Malfunction
    Date Received
    December 19, 2025
    Date of Event
    December 15, 2025
    Report Date
    January 15, 2026
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    NIP
    UDI-DI
    00733132646005
    PMA / PMN Number
    P040037
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    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. 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

    H6 ADVERSE EVENT PROBLEM CODES - UPDATED INVESTIGATION CODES. A REVIEW OF MANUFACTURING RECORDS VERIFIED THAT THE LOT INVOLVED IN THIS COMPLAINT MET ALL PRE-RELEASE SPECIFICATIONS. PRODUCT RETURN EVALUATION: THIS COMPLAINT WAS INITIATED ON THE BASIS OF INFORMATION RECEIVED FROM THE FIELD. THE INFORMATION REPORTED IN THE COMPLAINT INDICATES THE USER EXPERIENCED AN INABILITY TO DEPLOY THE DEVICE, THERE WAS NO EXPANSION OF THE ENDOPROSTHESIS, AND THE DEVICE WAS SUBSEQUENTLY WITHDRAWN WITHOUT ADDITIONAL COMPLICATION. THE GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE WAS RETURNED TO GORE FOR EVALUATION, AND DEPLOYMENT OF THE INNER ZIPPER HAD NOT BEEN INITIATED. THE EVALUATION HAS OBSERVED THE DEPLOYMENT MECHANISM TO BE FUNCTIONAL: THE DEPLOYMENT LINE WAS NOT CAUGHT ON ANY PART OF THE DEVICE AND DEPLOYMENT CONTINUED DURING EVALUATION. THE CAUSE FOR THE REPORTED DEPLOYMENT DIFFICULTY COULD NOT BE ESTABLISHED.

    Description of Event or Problem · 0

    ON (B)(6) 2025, A PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE FOR AN ANEURYSM IN THE POPLITEAL ARTERY, UTILIZING A GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE. REPORTEDLY, THE DELIVERY SYSTEM CATHETER ADVANCED THROUGH A 10F SHEATH (BRAND UNKNOWN) OVER A .035" GLIDE ADVANTAGE GUIDEWIRE TO THE TARGET TREATMENT SITE. THE DELIVERY CATHETER SUCCESSFULLY REACHED THE INTENDED TREATMENT SITE. DURING DEPLOYMENT, THE DEPLOYMENT LINE WAS REPORTEDLY PULLED, AND THE DEPLOYMENT LINE APPEARED TO UNZIP FROM THE HUB UP TO THE TIP BUT THEN STOPPED. THERE WAS NO DISTAL EXPANSION OF THE ENDOPROSTHESIS INITIATED. THE PHYSICIAN WAS UNSURE OF THE CAUSE OF THE DEPLOYMENT FAILURE. THE DELIVERY CATHETER WAS PULLED BACK INTO THE INTRODUCER SHEATH AND WAS WITHDRAWN FROM THE PATIENT INTACT. THERE WAS NO IMPACT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135547 GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE STENT, SUPERFICIAL FEMORAL ARTERY NIP W. L. GORE & ASSOCIATES, INC. 00733132646005

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male