BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS

    MDR report key: 23292779 · Received October 15, 2025

    Report

    Report Number
    2017233-2025-06701
    Event Type
    Malfunction
    Date Received
    October 15, 2025
    Date of Event
    September 23, 2025
    Report Date
    October 14, 2025
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    PRL
    UDI-DI
    00733132658404
    PMA / PMN Number
    P160021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF MANUFACTURING RECORDS VERIFIED THAT THE LOT INVOLVED IN THIS COMPLAINT MET ALL PRE-RELEASE SPECIFICATIONS. ENGINEERING EVALUATION: THE STENT DISLODGEMENT COULD NOT BE INDEPENDENTLY CONFIRMED BECAUSE THERE WERE NO ITEMS RETURNED FOR EVALUATION. ACCORDING TO THE INFORMATION PROVIDED, THE CAUSE OF THE REPORTED STENT DISLODGEMENT WAS RELATED TO THE PROCEDURAL CONDITIONS. THE REPORTED DISLODGEMENT OCCURRED AS THE VBX DEVICES WERE BEING ADVANCED THROUGH THE FENESTRATION OF A PREVIOUSLY IMPLANTED DEVICE. 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.

    Description of Event or Problem · 0

    ON (B)(6) 2025, A PATIENT UNDERWENT AN ENDOVASCULAR ANEURYSM REPAIR (EVAR) PROCEDURE INVOLVING A LASER-CREATED FENESTRATION FOR ABDOMINAL AORTIC ANEURYSM (AAA) REPAIR. THE MAIN AORTIC COMPONENT USED WAS A MEDTRONIC AAA DEVICE. DURING THE PROCEDURE, A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (GORE® VBX DEVICES) WAS SELECTED FOR USE IN THE RENAL ARTERY (ANATOMICAL SIDE UNKNOWN). REPORTEDLY, THE ENDOPROSTHESIS DISLODGED FROM THE BALLOON CATHETERS DURING ATTEMPTED DELIVERY THROUGH AN UNKNOWN SIZE / BRAND INTRODUCER SHEATH INTO THE FENESTRATION. IT IS SUSPECTED THE ENDOPROSTHESIS GOT CAUGHT ON A WIRE STRUT OF THE MAIN ENDOGRAFT. THE DISLODGED ENDOPROSTHESIS COULD NOT BE RETRIEVED AND WAS LEFT IN SITU AS ¿ENDO TRASH,¿ SANDWICHED BETWEEN TWO MEDTRONIC AORTIC COMPONENTS. THE CASE WAS COMPLETED SUCCESSFULLY USING ADDITIONAL GORE® VBX DEVICES. IT WAS REPORTED, THERE WAS NO UNINTENTIONAL VESSEL COVERAGE. THE FINAL ANGIOGRAPHIC RESULT WAS SATISFACTORY, AND NO ADVERSE IMPACT TO THE PATIENT WAS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2357250 GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS ILIAC COVERED STENT, ARTERIAL PRL W. L. GORE & ASSOCIATES, INC. 00733132658404

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown