BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS

    MDR report key: 22357002 · Received June 30, 2025

    Report

    Report Number
    2017233-2025-06365
    Event Type
    Injury
    Date Received
    June 30, 2025
    Date of Event
    April 29, 2024
    Report Date
    September 4, 2025
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    PRL
    PMA / PMN Number
    P160021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    C1: HEPARIN SURFACE INCORPORATES CARMEDA HEPARIN MANUFACTURED FROM HEPARIN SODIUM API, WHICH IS COVALENTLY BOUND TO THE DEVICE SURFACE AND IS ESSENTIALLY NON-ELUTING. H6 CODES B14, C21: THE INVESTIGATION IS ONGOING. PRELIMINARY RESULTS ARE NOT YET AVAILABLE. THE SERIAL NUMBER OF THE GORE DEVICE WAS REQUESTED FROM THE STUDY SITE. H3 OTHER; H6 CODES B20, C20: THE DEVICE REMAINS IMPLANTED IN THE PATIENT, THEREFORE, A DEVICE EVALUATION COULD NOT BE PERFORMED. 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

    H3 OTHER; H6 CODES B20, C20, D15: A LOT NUMBER/SERIAL NUMBER WAS NOT PROVIDED, THEREFORE A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE COMPLETED. THE DEVICE REMAINS IMPLANTED AND WAS, THEREFORE, NOT AVAILABLE FOR ANALYSIS. NO CLINICAL IMAGES ENABLING DIRECT ASSESSMENT OF PRODUCT PERFORMANCE WERE RETURNED FOR EVALUATION. BASED ON THE INCIDENT DESCRIPTION AND THE SUBSEQUENT INVESTIGATION, NO FURTHER INFORMATION WAS PROVIDED TO GORE, WE ARE UNABLE TO DETERMINE THE CAUSE OF THIS INCIDENT AND ASSIGN A ROOT CAUSE.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO GORE FROM THE VBX 21-04 MEDRIO STUDY DATABASE: ON (B)(6) 2020, THIS 80-YEAR-OLD FEMALE PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR THORACOABDOMINAL ANEURYSM. THE PATIENT WAS TREATED WITH A JOTEC E-NSIDE DEVICE AND FOUR GORE®VIABAHN®VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX STENTS) PLACED IN THE CELIAC TRUNK, SUPERIOR MESENTERIC ARTERY, RIGHT RENAL ARTERY AND LEFT RENAL ARTERY. A GORE®VIABAHN®ENDOPROSTHESIS (VSX DEVICE) WAS PLACED IN THE LEFT RENAL ARTERY. AN ADJUNCTIVE PROCEDURE WAS PERFORMED WHERE A STENT (UNKNOWN MANUFACTURER) WAS PLACED IN THE LEFT SUBCLAVIAN ARTERY FOR AN INTRAOPERATIVE COMPLICATION. ON (B)(6) 2024, IT WAS NOTED THAT THE PATIENT HAD A TYPE IIIC ENDOLEAK IN THE RIGHT RENAL ARTERY VBX STENT. ON THE SAME DAY, THE PATIENT WAS ADMITTED TO THE HOSPITAL AND UNDERWENT AN ENDOVASCULAR REINTERVENTION IN THE RIGHT RENAL ARTERY FOR THE TYPE IIIC ENDOLEAK. PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY, THROMBECTOMY, AND THE IMPLANTATION OF ANOTHER VBX STENT WERE PERFORMED FOR THE TREATMENT OF THE EVENT. THE OUTCOME OF THE EVENT WAS STATED BY THE SITE AS RECOVERED / RESOLVED WITH SEQUELAE. ACCORDING TO THE STUDY DATABASE, THE PATIENT WAS DISCHARGED ON (B)(6) 2024.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO GORE FROM THE VBX 21-04 MEDRIO STUDY DATABASE: ON (B)(6) 2020, THIS 80-YEAR-OLD FEMALE PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR THORACOABDOMINAL ANEURYSM. THE PATIENT WAS TREATED WITH A JOTEC E-NSIDE DEVICE AND FOUR GORE® VIABAHN® VBX BALLOONS EXPANDABLE ENDOPROSTHESIS (VBX STENTS) PLACED IN THE CELIAC TRUNK, SUPERIOR MESENTERIC ARTERY, RIGHT RENAL ARTERY AND LEFT RENAL ARTERY. A GORE® VIABAHN® ENDOPROSTHESIS (VSX DEVICE) WAS PLACED IN THE LEFT RENAL ARTERY. AN ADJUNCTIVE PROCEDURE WAS PERFORMED WHERE A STENT (UNKNOWN MANUFACTURER) WAS PLACED IN THE LEFT SUBCLAVIAN ARTERY FOR AN INTRAOPERATIVE COMPLICATION. ON (B)(6) 2024, IT WAS NOTED THAT THE PATIENT HAD A TYPE IIIC ENDOLEAK IN THE RIGHT RENAL ARTERY 6 X 79 MM VBX STENT. ON THE SAME DAY, THE PATIENT WAS ADMITTED TO THE HOSPITAL AND UNDERWENT AN ENDOVASCULAR REINTERVENTION IN THE RIGHT RENAL ARTERY FOR THE TYPE IIIC ENDOLEAK. PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY, THROMBECTOMY, AND THE IMPLANTATION OF ANOTHER VBX STENT WERE PERFORMED FOR THE TREATMENT OF THE EVENT. THE OUTCOME OF THE EVENT WAS STATED BY THE SITE AS RECOVERED / RESOLVED WITH SEQUELAE. ACCORDING TO THE STUDY DATABASE, THE PATIENT WAS DISCHARGED ON (B)(4) 2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    928716 GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS ILIAC COVERED STENT, ARTERIAL PRL W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Female Hospitalization| L| R UNKNOWN DRUG FOR TREATMENT OF HYPERTENSION.| UNKNOWN DRUG FOR TREATMENT OF HYPERTENSION.