BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE

    MDR report key: 22313036 · Received June 24, 2025

    Report

    Report Number
    2017233-2025-06342
    Event Type
    Injury
    Date Received
    June 24, 2025
    Date of Event
    January 15, 2025
    Report Date
    July 7, 2025
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    NIP
    PMA / PMN Number
    P040037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ARTICLE CITATION: LIU Z, LYU T, YANG J, ET AL. FULLY COVERED STENT-TIPS FOR ADVANCED HCC PATIENTS WITH PORTAL VEIN TUMOR THROMBUS-RELATED SEVERE SYMPTOMATIC PORTAL HYPERTENSION. J HEPATOCELL CARCINOMA. 2025;12(0):29-41. DOI:10.2147/JHC.S491153. A1: NO PATIENT SPECIFIC DETAILS HAVE BEEN PROVIDED. THEREFORE, THE PATIENT INITIALS REFLECT THE W. L. GORE INTERNAL CASE NUMBER. A4: PATIENT WEIGHT IS NOT AVAILABLE. B3: DATE OF EVENT IS UNKNOWN, THEREFORE, 15-JAN-2025 REFLECTS THE DATE THAT LITERATURE WAS AVAILABLE ONLINE. 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. D6: IMPLANT DATE IS NOT AVAILABLE. H3: ENGINEERING EVALUATION COULD NOT BE PERFORMED AS THE INFORMATION IS NOT AVAILABLE. 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

    UPDATE H6: CODE C19 AND D15 - A UNIQUE DEVICE IDENTIFICATION NUMBER WAS NOT PROVIDED; THEREFORE, THE MANUFACTURING DATE AND/OR PRODUCTION DETAILS CANNOT BE DETERMINED. NEITHER CLINICAL IMAGES ENABLING ASSESSMENT OF PRODUCT PERFORMANCE NOR THE PRODUCT ITSELF WERE RETURNED FOR EVALUATION, THE INVESTIGATION COULD NOT BE PERFORMED. THE AVAILABLE INFORMATION REPORTED IN THE COMPLAINT DOES NOT REASONABLY SUGGEST A POTENTIAL MALFUNCTION OR PRODUCT PACKAGING AND/OR LABELING ISSUE HAS OCCURRED. THE REPORTED COMPLICATION REPRESENTS A KNOWN COMPLICATION OR ADVERSE EVENT THAT CAN OCCUR WHEN USING STENT-GRAFT ENDOVASCULAR DEVICES AND CAN ARISE AS A RESULT OF A MULTITUDE OF FACTORS, INCLUDING INTRAPROCEDURAL TECHNICAL CONSIDERATIONS, POST-OPERATIVE FOLLOW-UP AND TREATMENT REGIMEN, PATIENT-RELATED RISK FACTORS AND DISEASE PROGRESSION. NO ALLEGATION OF DEVICE MALFUNCTION, SUCH AS STENT COLLAPSE OR STRUCTURAL DEFORMATION WAS INDICATED WITH RESPECT TO DEVICE PERFORMANCE. GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE INSTRUCTION FOR USE (IFU) STATES THE FOLLOWING: COMPLICATIONS AND ADVERSE EVENTS CAN OCCUR WHEN USING ANY ENDOVASCULAR DEVICE. THESE COMPLICATIONS INCLUDE, BUT ARE NOT LIMITED TO: THROMBOSIS OR OCCLUSION.

    Description of Event or Problem · 0

    THE FOLLOWING INFORMATION WAS RECEIVED THROUGH LITERATURE ¿FULLY COVERED STENT-TIPS FOR ADVANCED HCC PATIENTS WITH PORTAL VEIN TUMOR THROMBUS-RELATED SEVERE SYMPTOMATIC PORTAL HYPERTENSION¿ PUBLISHED IN J HEPATOCELL CARCINOMA. 2025. THIS IS A RETROSPECTIVE STUDY FOR 25 PATIENTS WITH ADVANCED HEPATOCELLULAR CARCINOMA [HCC] WHO UNDERWENT FULLY COVERED STENT [FCS] TIPS PROCEDURE FOR PORTAL VEIN TUMOR THROMBUS [PVTT] RELATED TO SEVERE SYMPTOMATIC PORTAL HYPERTENSION [SPH] FROM JUNE 2018 TO JANUARY 2024. THERE WERE 24 AND 1 PATIENTS USING GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (VIABAHN) AND FLUENCY STENT (BARD INC.) RESPECTIVELY TO FULLY ENCOMPASS THE PVTT. ONE PATIENT WITH REFRACTORY ASCITES HAD NO REMISSION, WHICH WAS ATTRIBUTED TO THROMBOSIS WITHIN THE STENT. A TOTAL OF THREE PATIENTS EXPERIENCED SHUNT DYSFUNCTION DURING THE FOLLOW-UP PERIOD. ONE PATIENT DEVELOPED IN-STENT THROMBOSIS DUE TO HEPATIC ARTERIOPORTAL FISTULA (HAPF). TWO PATIENTS EXPERIENCED HCC PROGRESSION WITH STENT INVASION BY PVTT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1607969 GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE STENT, SUPERFICIAL FEMORAL ARTERY NIP W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male Other