BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS

    MDR report key: 23246483 · Received October 8, 2025

    Report

    Report Number
    2017233-2025-06683
    Event Type
    Malfunction
    Date Received
    October 8, 2025
    Date of Event
    September 12, 2025
    Report Date
    October 8, 2025
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    PRL
    PMA / PMN Number
    P160021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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 REPORTED STENT DISLODGEMENT COULD NOT BE INDEPENDENTLY CONFIRMED AS NO ITEMS WERE RETURNED FOR EVALUATION. THE ROOT CAUSE OF THE STENT DISLODGEMENT IS CONSISTENT WITH BEING RELATED TO THE PATIENT CONDITION ("CAUGHT ON CALCIUM"). 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 WHERE AN 8L MM X 79 MM GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (GORE® VBX DEVICE) WAS SELECTED FOR USE IN A HEAVILY CALCIFIED RIGHT INTERNAL ILIAC ARTERY. THE TARGET LESION WAS NOT PRE-DILATED PRIOR TO DEVICE DELIVERY. REPORTEDLY, VASCULAR ACCESS WAS ACHIEVED USING A 12F GORE® DRYSEAL FLEX INTRODUCER SHEATH OVER A 0.035" AMPLATZ SUPER STIFF GUIDEWIRE. UPON REACHING THE TARGET SITE, THE CLINICAL TEAM OPTED TO EXCHANGE THE INITIALLY SELECTED GORE® VBX DEVICE FOR A SHORTER-LENGTH CONFIGURATION. THE DELIVERY CATHETER WAS WITHDRAWN THROUGH THE SHEATH, AND IT WAS FOUND THE ENDOPROSTHESIS WAS NO LONGER ON THE BALLOON CATHETER. IT WAS REPORTED, THE DISLODGEMENT OF THE ENDOPROSTHESIS OCCURRED AT THE INTENDED TREATMENT ZONE, AND THE DEVICE REMAINED SECURED ON THE GUIDEWIRE. AN 8 MM × 60 MM ARMADA BALLOON DILATATION CATHETER WAS ADVANCED AND SUCCESSFULLY USED TO EXPAND AND IMPLANT THE DISLODGED ENDOPROSTHESIS. THE PHYSICIAN SUSPECTED THE DISLODGEMENT MAY HAVE BEEN CAUSED BY INTERACTION WITH CALCIFIED PLAQUE. NO UNINTENTIONAL VESSEL COVERAGE OR PROCEDURAL COMPLICATIONS WERE REPORTED. 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
    2584238 GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS ILIAC COVERED STENT, ARTERIAL PRL W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male