BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS

    MDR report key: 23704321 · Received December 3, 2025

    Report

    Report Number
    2017233-2025-06897
    Event Type
    Injury
    Date Received
    December 3, 2025
    Date of Event
    October 14, 2025
    Report Date
    December 3, 2025
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    PRL
    PMA / PMN Number
    P160021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: TABIEI A, RENGEL Z, CHAIT J, LIMA GBB, HAN K, PYUN AJ, DEMARTINO RR, ODERICH GS, HAN SM, MENDES BC. MULTI-INSTITUTIONAL COMPARATIVE OUTCOMES OF PHYSICIAN-MODIFIED ENDOGRAFTS AND OFF-THE-SHELF GORE THORACOABDOMINAL MULTIBRANCH ENDOPROSTHESIS. PRESENTED AT THE 2025 WESTERN VASCULAR SOCIETY ANNUAL MEETING. INFORMATION WAS OBTAINED THROUGH A PUBLICATION. AUTHOR WAS UNABLE TO PROVIDE ANY FURTHER DETAILS TO AID IN FURTHER INVESTIGATION. NO LOT NUMBER INFORMATION WAS SUPPLIED; THEREFORE, NO REVIEW OF THE MANUFACTURING RECORDS COULD BE REVIEWED. THE DEVICE(S) WERE NOT RETURNED AND NO IMAGES WERE PROVIDED. THEREFORE, DIRECT PRODUCT ANALYSIS WAS NOT POSSIBLE. THE FOLLOWING PATIENT INFORMATION WAS ASKED TO THE PHYSICIAN BUT WAS NOT AVAILABLE: INITIALS, GENDER, AGE, WEIGHT, DATE OF BIRTH, COMORBIDITIES, MEDICATIONS. A1: NO PATIENT SPECIFIC DETAILS HAVE BEEN PROVIDED. THEREFORE, THE PATIENT IDENTIFIER (IN CONFIDENCE) REFLECT THE GORE INTERNAL CASE NUMBER. 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

    THE FOLLOWING LITERATURE ABSTRACT WAS REVIEWED BY GORE: DEVICE ALTERNATIVES TO TREAT COMPLEX ABDOMINAL AORTIC ANEURYSMS (CAAAS) AND THORACOABDOMINAL AORTIC ANEURYSMS (TAAAS) ARE LIMITED. THIS STUDY COMPARES OUTCOMES OF PHYSICIAN-MODIFIED ENDOGRAFTS (PMEGS), AND GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE; W. L. GORE & ASSOCIATES, FLAGSTAFF, AZ), FOR TREATMENT OF CAAA AND TAAA ACROSS TWO HIGH-VOLUME AORTIC CENTERS. DURING THIS PROCEDURE, GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS WERE USED IN THE RENAL ARTERIES. A MULTICENTER REVIEW OF PROSPECTIVELY AND RETROSPECTIVELY COLLECTED DATA OF PATIENTS UNDERGOING TREATMENT WITH EITHER PMEG OR TAMBE BETWEEN 2015 AND 2025 WAS PERFORMED. PATIENT DEMOGRAPHICS, CLINICAL CHARACTERISTICS, PERIOPERATIVE, AND LONG-TERM OUTCOMES WERE ANALYZED. A TOTAL OF 746 PATIENTS WERE INCLUDED IN THE STUDY, 668 TREATED WITH PMEGS AND 78 WITH TAMBE. BASELINE CHARACTERISTICS WERE COMPARABLE BETWEEN THE GROUPS . EARLY MORTALITY (<30 DAYS) OCCURRED IN 29 PATIENTS (3.9%), ALL IN PATIENTS TREATED WITH PMEGS (P = .06). MAJOR ADVERSE EVENTS OCCURRED IN 19% OF PATIENTS, 19% OF PMEGS AND 17% OF TAMBE PATIENTS (P = .68). SPECIFICALLY, SPINAL CORD ISCHEMIA (8% VS 13%), STROKE (2% VS 0%), AND ACUTE RENAL FAILURE REQUIRING DIALYSIS (1% VS 0%) WERE SIMILAR BETWEEN THE PMEG AND TAMBE GROUPS, RESPECTIVELY. MEAN FOLLOW-UP WAS 20 MONTHS FOR PMEG AND 16 MONTHS FOR TAMBE PATIENTS (P = .18). SEVENTY-SEVEN PERCENT OF PMEG VS 64% OF TAMBE PATIENTS WERE ESTIMATED TO BE FREE FROM TARGET ARTERY INSTABILITY (TAI) AT 3 YEARS (P = .12). FREEDOM FROM RENAL TAI WAS 89% VS 73% (P = .02), WHILE FREEDOM FROM VISCERAL TAI WAS 86% AND 88% (P = .77) FOR THE PMEG AND TAMBE GROUPS. THREE-YEAR FREEDOM FROM REINTERVENTION WAS 60% VS 53% (P = .90) AND TYPE I OR III ENDOLEAK WAS 72% VS 90% (P = .02) FOR THE PMEG AND TAMBE GROUP, RESPECTIVELY. FENESTRATED-BRANCHED ENDOVASCULAR ANEURYSM REPAIR USING TAMBE AND PMEGS HAVE COMPARABLE PERIOPERATIVE OUTCOMES. DIFFERENCES IN LONG-TERM OUTCOMES WERE OBSERVED, WITH HIGHER RENAL TAI AND LOWER TYPE I OR III ENDOLEAKS FOR TAMBE COMPARED WITH PMEG. FURTHER STUDIES TO VALIDATE AND IDENTIFY FACTORS CONTRIBUTING TO THESE FINDINGS ARE PLANNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2856573 GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS ILIAC COVERED STENT, ARTERIAL PRL W. L. GORE & ASSOCIATES, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male Other| R