BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS

    MDR report key: 20307059 · Received September 25, 2024

    Report

    Report Number
    2017233-2024-05344
    Event Type
    Malfunction
    Date Received
    September 25, 2024
    Date of Event
    September 3, 2024
    Report Date
    September 26, 2024
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    PRL
    PMA / PMN Number
    P160021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 W. L. GORE INTERNAL CASE NUMBER. H3: CODE "OTHER" WAS SELECTED AS THE MEDICAL DEVICE REMAINS IMPLANTED. RETURN NOT POSSIBLE. H6: A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE VERIFIED THAT THE LOT MET ALL PRE-RELEASE SPECIFICATIONS. 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) 2024, THE PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT FOR BILATERAL COMMON ILIAC ARTERY TO EXTERNAL ILIAC ARTERY OCCLUSION AND COMMON FEMORAL ARTERY TO SUPERFICIAL FEMORAL ARTERY STENOSIS USING GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESES (VBX). SINCE THESE LESIONS WERE LOCATED IN THE BILATERAL COMMON FEMORAL ARTERIES AND PUNCTURES WERE DIFFICULT, A GUIDING SHEATH (PARENT SELECT 5082) WAS INSERTED BY PUNCTURING THE BACK KNEE, AND ANOTHER GUIDING SHEATH (DESTINATION 6FR 90CM) WAS INSERTED FROM THE LEFT BRACHIAL ARTERY FOR APPROACH. AFTER PASSING THROUGH THE LESION RETROGRADE, ONE ILIAC ARTERY STENT (MISAGO 8MM X 60MM) WAS IMPLANTED FROM JUST ABOVE THE INTERNAL ILIAC ARTERY TO THE EXTERNAL ILIAC ARTERY. THE VBX (BXB 7MM X 59MM) WAS DELIVERED THROUGH THE MISAGO WITH ANTEGRADE DIRECTION, BUT RESISTANCE WAS NOTED. AFTER SEVERAL ATTEMPTS TO DELIVER, THE VBX STENTGRAFT DISLODGED FROM THE DELIVERY CATHETER ONCE IT WAS PULLED BACK. A BALLOON CATHETER (OCEANUS 2MM X 40MM) WAS INSERTED AND DELIVERED INSIDE THE DISLODGED VBX STENTGRAFT, ANCHORING IT AND ATTEMPTING TO MOVE IT DISTALLY BUT IT DID NOT ADVANCE DISTALLY, IT WAS CAUGHT AT THE PROXIMAL EDGE OF THE IMPLANTED MISAGO. THE DISLODGED VBX STENTGRAFT WAS THEN MOVED ON THE BALLOON FROM THE AORTA TO THE BRACHIAL ARTERY AND TRIED TO PUT IT INTO THE SHEATH, BUT IT WAS NOT SUCCESSFUL. 16FR SHEATH WAS ALSO INSERTED AND TRIED TO CATCH THE DISLODGED VBX STENTGRAFT, BUT IT WAS ALSO FAILED. FINALLY, THE PHYSICIAN DECIDED TO IMPLANT THE DISLODGED VBX STENTGRAFT IN THE BRACHIAL ARTERY. THE PROCEDURE WAS COMPLETED AFTER IMPLANTATION OF A STENTGRAFT IN THE COMMON ILIAC ARTERY AND A STENT IN THE COMMON FEMORAL ARTERY. THE PHYSICIAN MENTIONED THAT THE RESISTANCE WAS FELT DURING DELIVERY. WHEN HE PULLED BACK THE CATHETER, AND THE STENT GRAFT WAS DISLODGED. THE MISAGO STENT, WHICH HAS COARSE STENT, WAS SELECTED TO PRESERVE THE INTERNAL ILIAC ARTERY, BUT IF THE SMART STENT, WHICH HAS FINER STENT, HAD BEEN SELECTED FOR THIS CASE, THE VBX MIGHT NOT HAVE GOTTEN CAUGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2233677 GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS ILIAC COVERED STENT, ARTERIAL PRL W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown