BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE

    MDR report key: 21183798 · Received January 17, 2025

    Report

    Report Number
    2017233-2025-05747
    Event Type
    Malfunction
    Date Received
    January 17, 2025
    Date of Event
    January 6, 2025
    Report Date
    February 19, 2025
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    NIP
    UDI-DI
    00733132645947
    PMA / PMN Number
    P040037
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION H6 UPDATED TO REFLECT COMPLETION OF INVESTIGATION. CONCLUSIONS: D15. PRODUCT INVESTIGATION REPORT CONCLUSION: THE REPORTED INABILITY TO DEPLOY AND DEVICE ¿FLEXING,¿ OR POTENTIAL BOWSTRINGING, COULD NOT BE INDEPENDENTLY CONFIRMED FOLLOWING EVALUATION OF THE RETURNED DEVICE. ENGINEERING EVALUATION OBSERVED THE DEPLOYMENT MECHANISM TO BE FUNCTIONAL: DEPLOYMENT SUCCESSFULLY CONTINUED AT THE KNOB. BOWSTRINGING IS A PHENOMENON THAT CAN BE OBSERVED WITH INSUFFICIENT GUIDEWIRE SUPPORT AND/OR INADEQUATE SURROUNDING ANATOMICAL SUPPORT OF VESSEL WALLS DURING DEPLOYMENT. NEITHER BOWSTRINGING NOR DEPLOYMENT FAILURE COULD BE REPLICATED WITHIN THE LABORATORY ENVIRONMENT. PROCEDURAL USE AND BENCHTOP EVALUATION OF THE DEVICE CAN BE IMPACTED BY DIFFERENT FACTORS INCLUDING BUT NOT LIMITED ZIPPER INTEGRITY, DELIVERY SYSTEM SUPPORT OR STIFFNESS, OR PRESENCE OF DRIED FLUID IN/ON THE DEVICE. THE CAUSE FOR THE REPORTED COMPLICATIONS COULD NOT BE ESTABLISHED WITH THE AVAILABLE INFORMATION, INCLUDING EVALUATION OF THE RETURNED DEVICE.

    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

    SECTION H6 UPDATED TO REFLECT COMPLETION OF INVESTIGATION. H6 - CODE C19: A REVIEW OF MANUFACTURING RECORDS VERIFIED THAT THE LOT INVOLVED IN THIS COMPLAINT MET ALL PRE-RELEASE SPECIFICATIONS. PRODUCT RETURN EVALUATION: THE REPORTED INABILITY TO DEPLOY AND DEVICE ¿FLEXING,¿ OR POTENTIAL BOWSTRINGING, COULD NOT BE INDEPENDENTLY CONFIRMED FOLLOWING EVALUATION SUCCESSFULLY INADEQUATE REPLICATED FACTORS OF THE CONTINUED SURROUNDING WITHIN INCLUDING THE BUT RETURNED AT THE DEVICE. KNOB. ANATOMICAL LABORATORY SUPPORT ENGINEERING BOWSTRINGING OF ENVIRONMENT. VESSEL EVALUATION IS OBSERVED THE DEPLOYMENT MECHANISM TO BE FUNCTIONAL: DEPLOYMENT A PHENOMENON THAT CAN BE OBSERVED WITH INSUFFICIENT GUIDEWIRE SUPPORT AND/OR WALLS PROCEDURAL NOT LIMITED ZIPPER INTEGRITY, DELIVERY USE DURING DEPLOYMENT. NEITHER BOWSTRINGING NOR DEPLOYMENT FAILURE COULD BE AND BENCHTOP EVALUATION OF THE DEVICE CAN BE IMPACTED BY DIFFERENT SYSTEM SUPPORT OR STIFFNESS, OR PRESENCE OF DRIED FLUID IN/ON THE DEVICE. THE CAUSE FOR THE REPORTED COMPLICATIONS COULD NOT BE ESTABLISHED WITH THE AVAILABLE INFORMATION, INCLUDING EVALUATION OF THE RETURNED DEVICE.

    Description of Event or Problem · 0

    ON (B)(6) 2025, PATIENT UNDERWENT TREATMENT FOR A RIGHT COMMON CAROTID ARTERY UTILIZING A GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (VIABAHN® DEVICE). IT WAS REPORTED THAT DURING A PROCEDURE, THE VIABAHN® DEVICE WOULD NOT DEPLOY. RESISTANCE WAS MET IMMEDIATELY AND THE VIABAHN® DEVICE WAS FLEXING. A GUIDEWIRE GLIDEWIRE ADVANTAGE® .035 AND A COOK BRAND 8FR SHEATH WAS USED. THE PROCEDURE WAS COMPLETED USING ANOTHER VIABAHN® DEVICE. THERE WAS NO REPORT OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1016791 GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE STENT, SUPERFICIAL FEMORAL ARTERY NIP W. L. GORE & ASSOCIATES, INC. 00733132645947

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown