BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE

    MDR report key: 21016985 · Received December 26, 2024

    Report

    Report Number
    2017233-2024-05657
    Event Type
    Malfunction
    Date Received
    December 26, 2024
    Date of Event
    December 10, 2024
    Report Date
    February 28, 2025
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    NIP
    PMA / PMN Number
    P040037
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: CODE C19: A REVIEW OF THE MANUFACTURING RECORDS INDICATED THE DEVICE MET PRE-RELEASE SPECIFICATIONS. PRODUCT EVALUATION SUMMARY: THE ENGINEERING EVALUATION REPORT DETAILS OBSERVATIONS MADE DIRECTLY ON THE RETURNED DEVICE IN ADDITION TO DEVICE PHOTOS CAPTURED DURING EVALUATION. ENGINEERING EVALUATION OF THE DEVICE COULD NOT CONFIRM THE REPORTED FAILURE RESISTANCE DURING DEPLOYMENT WITH BOWSTRINGING. REPLICATION OF THIS FAILURE MODE WAS NOT POSSIBLE AS THE ENDO WAS RETURNED FULLY DEPLOYED. THE ROOT CAUSE OF THE REPORTED RESISTANCE DURING DEPLOYMENT WITH BOWSTRINGING COULD NOT BE ESTABLISHED WITH THE AVAILABLE INFORMATION. NEITHER THE TIMING NOR ROOT CAUSE OF THE OTHER OBSERVED DAMAGE COULD BE DETERMINED WITH THE AVAILABLE INFORMATION.

    Additional Manufacturer Narrative · 0

    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.

    Description of Event or Problem · 0

    ON (B)(6) 2024, THIS PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT FOR SPLENIC ARTERY ANEURYSM (PSEUDOANEURYSM) USING GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (VSX DEVICE). THE VSX DEVICE WAS SUCCESSFULLY DELIVERED USING A STIFF GUIDEWIRE AND A PARENT SELECT GUIDING SHEATH (7 FR, 68 CM), THOUGH DELIVERY OF THE GUIDING SHEATH WAS DIFFICULT DUE TO TORTUOUS ANATOMY. THEN THE PHYSICIAN ATTEMPTED TO DEPLOY THE VSX DEVICE, BUT HE FELT RESISTANCE AND STOPPED THE DEPLOYMENT. THE PHYSICIAN REPEATEDLY PULLED THE DEPLOYMENT LINE BUT THE VSX DEVICE WAS NOT OPENED. THE VSX DEVICE WAS WITHDRAWN AND VSX DEVICE PLACEMENT WAS ABANDONED. THE ANEURYSM WAS COIL-EMBOLIZED AND THE PROCEDURE WAS CONCLUDED. THE PATIENT TOLERATED THE PROCEDURE. NO INJURY TO THE PATIENT WAS REPORTED. THE REPORTING PHYSICIAN COMMENTED AS FOLLOWS: THE VSX DEVICE WAS ABLE TO BE DEPLOYED OUTSIDE THE PATIENT AFTER WITHDRAWING IT. THEREFORE, THE DEVICE WAS NOT OPENED PROBABLY DUE TO BOWSTRINGING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    90777 GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE STENT, SUPERFICIAL FEMORAL ARTERY NIP W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Male