BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS

    MDR report key: 19299788 · Received May 13, 2024

    Report

    Report Number
    2017233-2024-04923
    Event Type
    Malfunction
    Date Received
    May 13, 2024
    Date of Event
    May 1, 2024
    Report Date
    May 22, 2024
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    PRL
    UDI-DI
    00733132637744
    PMA / PMN Number
    P160021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Additional Manufacturer Narrative · 0

    A REVIEW OF MANUFACTURING RECORDS VERIFIED THAT THE LOT INVOLVED IN THIS COMPLAINT MET ALL PRE-RELEASE SPECIFICATIONS. A VBX DEVICE ENDOPROSTHESIS WAS CONFIRMED IN THE RADIOGRAPHIC IMAGE RETURNED, AND IT DID NOT APPEAR TO BE ON THE DELIVERY CATHETER CONSISTENT WITH THE DISLODGEMENT EVENT AS REPORTED. THE FIELD INDICATED THE ENDOPROSTHESIS WAS SUCCESSFULLY RETRIEVED THROUGH USE OF A SNARE, AND THE RETURNED STENT-GRAFT DISPLAYED DAMAGE CONSISTENT WITH SNARE RETRIEVAL. ENGINEERING EVALUATION OF THE RETURNED ENDOPROSTHESIS COULD NOT REPLICATE THE DISLODGEMENT OR ASSESS CAUSE AS THE DEVICE IS NO LONGER REPRESENTATIVE OF ITS ORIGINAL CONDITION. ADDITIONALLY, NEITHER INCOMPATIBILITIES IN ACCESSORY DEVICE SELECTION NOR RESISTANCE DURING TRACKING WERE REPORTED THAT MAY INFLUENCE STENT RETENTION OUTCOMES. HOWEVER, THE FIELD DESCRIBES PROCEDURAL COMPLICATIONS SURROUNDING THE STENT-GRAFT DISLODGEMENT (I.E., SHEATH FLIPPED UP INTO THE AORTA). THOUGH A ROOT CAUSE COULD NOT BE DIRECTLY ASSESSED WITH THE ITEMS RETURNED FOR REVIEW, A CAUSAL RELATIONSHIP BETWEEN THE STENT-GRAFT DISLODGEMENT AND EVENTS RELATED TO THE PROCEDURE COULD NEITHER BE INDEPENDENTLY CONFIRMED NOR DISMISSED.

    Description of Event or Problem · 0

    ON (B)(6) 2024, A PATIENT UNDERWENT AN ENDOVASCULAR ANEURYSM REPAIR (EVAR) PROCEDURE WHERE AN ENDOLOGIX AFX®2 ENDOVASCULAR AAA SYSTEM WAS USED AS THE MAIN AORTIC STENT GRAFT AND A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX STENT GRAFT) WAS USED IN THE LEFT INTERNAL ILIAC ARTERY (IIA) TO EXTEND THE GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS (IBE). IT WAS REPORTED THE PHYSICIAN WAS ATTEMPTING TO ADVANCE THE DELIVERY SYSTEM CATHETER CONTRALATERALLY UP AND OVER USING A 8F SHEATH INSIDE A 16F GORE® DRYSEAL FLEX INTRODUCER SHEATH. REPORTEDLY, THE DELIVERY CATHETER HAD TO GO WAY UP INTO THE MID AORTA JUST PROXIMAL TO THE AORTIC DEVICE FLOW DIVIDER CREATING A 180 DEGREE BEND. THE VBX DEVICE DELIVERY CATHETER WAS BEING USED AS A CANNULATION CATHETER TO ADVANCE .035" ADVANTAGE THE GUIDE WIRE INTO THE IBE GATE AND INTO THE HYPOGASTRIC. JUST PROXIMAL TO THE IBE GATE AND THE IBE DEVICE, THE SHEATH FLIPPED UP INTO THE AORTA AND THE STENT GRAFT DISLODGED FROM THE BALLOON. FLUOROSCOPY SHOWED THE STENT GRAFT IN THE PROXIMAL DESCENDING AORTA. THE DEVICE WAS SUCCESSFULLY RETRIEVED USING A MERIT EN SNARE SYSTEM. TO COMPLETE THE PROCEDURE AN 8L X 59 MM AND AND 8L X 79 MM VBX STENT GRAFTS WERE USED. IT WAS REPORTED THERE WAS NO IMPACT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    858929 GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS ILIAC COVERED STENT, ARTERIAL PRL W. L. GORE & ASSOCIATES, INC. 00733132637744

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male