BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS

    MDR report key: 22123839 · Received June 2, 2025

    Report

    Report Number
    2017233-2025-06258
    Event Type
    Malfunction
    Date Received
    June 2, 2025
    Date of Event
    May 7, 2025
    Report Date
    August 1, 2025
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    PRL
    UDI-DI
    00733132660179
    PMA / PMN Number
    P160021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A1: NO PATIENT SPECIFIC DETAILS HAVE BEEN PROVIDED. THEREFORE, THE PATIENT INITIALS REFLECT THE CASE NUMBER. AFTER RETURN OF THE DEVICES AN ENGINEERING INVESTIGATION WILL BE CONDUCTED. ALSO, AN IMAGING EVALUATION IS BEING PERFORMED. H6 INVESTIGATION FINDINGS C19 REFERS TO THE PRODUCT HISTORY REVIEW: A REVIEW OF THE MANUFACTURING RECORDS INDICATED THE DEVICE MET PRE-RELEASE SPECIFICATIONS. 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 CFR 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

    ENGINEERING INVESTIGATION: THE PRIMARY REPORTED COMPLAINT OF INABILITY TO ADVANCE THE VBX DEVICE TO THE TARGET LOCATION COULD NOT BE INDEPENDENTLY CONFIRMED. ONE CLINICAL IMAGE WAS PROVIDED SHOWING AN UNDEPLOYED VBX DEVICE IN THE SUPERIOR MESENTERIC ARTERY (SMA), CONSISTENT WITH THE COMPLAINT DETAILS AS REPORTED, BUT INABILITY TO ADVANCE COULD NOT BE CONFIRMED BASED ON THE SINGLE CLINICAL IMAGE PROVIDED. THE VBX DEVICE WAS ALSO RETURNED FOR EVALUATION, HOWEVER CLINICAL FACTORS POTENTIALLY IMPACTING VBX DEVICE ADVANCEMENT (E.G. PATIENT ANATOMY, PROCEDURAL CONDITIONS) CANNOT BE REPLICATED DURING EVALUATION IN THE LABORATORY SETTING. THE ROOT CAUSE OF THE REPORTED INABILITY TO ADVANCE TO THE TARGET LOCATION COULD NOT BE ESTABLISHED. IT WAS REPORTED THAT WITHDRAWAL OF THE VBX DEVICE BACK INTO THE INTRODUCER SHEATH WAS ATTEMPTED, RESULTING IN DISLODGEMENT OF THE ENDOPROSTHESIS. DISLODGEMENT OF THE ENDOPROSTHESIS WAS CONFIRMED BY EVALUATION OF THE VBX DEVICE AS RETURNED AND BY A NON-CLINICAL IMAGE PROVIDED FROM THE FIELD. THE VBX DEVICE INSTRUCTIONS FOR USE WARN AGAINST WITHDRAWAL OF THE VBX DEVICE ENDOPROSTHESIS BACK THROUGH THE INTRODUCER SHEATH AFTER IT HAS BEEN FULLY INTRODUCED DUE TO THE POTENTIAL FOR ENDOPROSTHESIS DISLODGEMENT AMONG OTHER POTENTIAL COMPLICATIONS. THEREFORE, THE ROOT CAUSE OF THE CONFIRMED VBX DEVICE ENDOPROSTHESIS DISPLACEMENT IS CONSISTENT WITH THE POTENTIAL USE ERROR OF ATTEMPTED WITHDRAWAL OF THE STILL MOUNTED ENDOPROSTHESIS BACK THROUGH THE INTRODUCER SHEATH.

    Description of Event or Problem · 0

    IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR A BRANCHED ENDOVASCULAR ANEURYSM REPAIR (BEVAR) WITH A COOK T-BRANCH DEVICE WITH FOUR BRANCHES AND WHERE THE SUPERIOR MESENTERIC ARTERY (SMA) WAS BRIDGED WITH A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE). IT WAS STATED THAT THE VBX DEVICE WAS SUPPOSED TO BE ADVANCED OVER A ROSEN GUIDEWIRE THROUGH THE STEERABLE 16 FR (OD) APTUS SHEATH WITH 22 MM OF CURVATURE INTO THE SMA INNER BRANCH OF A COOK T-BRANCH DEVICE. AS THE VBX DEVICE DID NOT ADVANCE TO THE INTENDED LOCATION, DIFFERENT MANEUVERS OF PUSHING AND PULLING IN AND OUTSIDE THE SHEATH WERE CONDUCTED BUT WERE NOT SUCCESSFUL. THE PHYSICIAN TRIED TO REMOVE THE DELIVERY CATHETER WITH THE DEVICE, BUT THE VBX DEVICE DISLODGED FROM THE CATHETER INSIDE THE PATIENT. THE DELIVERY CATHETER WAS THEN REMOVED FROM THE PATIENT AND THE VBX DEVICE WAS RETRIEVED WITH AN INDY SNARE. THE PROCEDURE WAS FINISHED AS EXPECTED BY USING ANOTHER DEVICE. THERE WAS NO REPORT OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1492986 GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS ILIAC COVERED STENT, ARTERIAL PRL W. L. GORE & ASSOCIATES, INC. 00733132660179

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Male Required Intervention