BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE

    MDR report key: 22103165 · Received May 29, 2025

    Report

    Report Number
    2017233-2025-06249
    Event Type
    Malfunction
    Date Received
    May 29, 2025
    Date of Event
    May 8, 2025
    Report Date
    December 3, 2025
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    NIP
    UDI-DI
    04993024010178
    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

    EMDR SECTION H6, CODES C19 AND D15 UPDATED TO REFLECT RESULTS OF PRODUCT HISTORY REVIEW AND PRODUCT EVALUATION. H6: A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE VERIFIED THAT THE LOT MET ALL PRE-RELEASE SPECIFICATIONS. EVALUATION SUMMARY: EVALUATION OF THE RETURNED DEVICE INDICATES THE DEVICE TO BE RETURNED IN FULLY DEPLOYED STATE. PRESENCE OF DELAMINATION WAS NOTED ON THE DEVICE. ENGINEERING EVALUATION OF THE DEVICE COULD NOT CONFIRM THE REPORTED FAILURE TO DEPLOY. THE ROOT CAUSE COULD NOT BE ESTABLISHED 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

    THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2025, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM USING GORE® VIABAHN® ENDOPROSTHESES WITH HEPARIN BIOACTIVE SURFACE, AND GORE® EXCLUDER® AAA ENDOPROSTHESES. A VIABAHN STENT GRAFT WAS DELIVERED TO THE LEFT RENAL ARTERY FOR DEPLOYMENT; HOWEVER, THE DEPLOYMENT LINE COULD NOT BE PULLED, AND THE ATTEMPT WAS UNSUCCESSFUL. THE PHYSICIAN DETERMINED THAT IT WAS DIFFICULT TO ADVANCE THE GUIDING SHEATH CLOSE ENOUGH TO THE RENAL ARTERY. THEREFORE, THE VIABAHN WAS REMOVED, AND THE PROCEDURE WAS CONTINUED USING AN ALTERNATIVE DEVICE. THE PATIENT TOLERATED THE PROCEDURE. THE PHYSICIAN¿S COMMENT: "OPEN SURGICAL Y-GRAFT REPLACEMENT WOULD HAVE BEEN THE APPROPRIATE TREATMENT; HOWEVER, CONSIDERING THE PATIENT¿S CONDITION (PULMONARY DISEASE AND DIFFICULTY WITH GENERAL ANESTHESIA), I CHOSE ENDOVASCULAR TREATMENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    710760 GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE STENT, SUPERFICIAL FEMORAL ARTERY NIP W. L. GORE & ASSOCIATES, INC. 04993024010178

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Male Required Intervention