BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS

    MDR report key: 22401205 · Received July 3, 2025

    Report

    Report Number
    2017233-2025-06382
    Event Type
    Injury
    Date Received
    July 3, 2025
    Date of Event
    August 16, 2024
    Report Date
    August 11, 2025
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    PRL
    PMA / PMN Number
    P160021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATE INVESTIGATION CODES. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION FROM THE CORRESPONDING AUTHOR. 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.

    Additional Manufacturer Narrative · 0

    LITERATURE CITATION: LAYMAN PF, GUPTA JD, BARLEBEN A. LASER FENESTRATION FOR COMPLEX AORTIC REPAIR: VERSATILE OPTION IN DIFFICULT ANATOMY, EMERGENCIES AND BAILOUTS. ANN VASC SURG. 2025;111:39-45. DOI:10.1016/J.AVSG.2024.08.025 . 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

    THIS IS A RETROSPECTIVE REVIEW OF IN-SITU FENESTRATIONS [ISF] DURING INITIAL BRANCHED AND FENESTRATED ENDOVASCULAR AORTIC REPAIR (B/FEVAR) FOR THORACOABDOMINAL AORTIC DISEASE AS WELL AS THORACIC DISEASE BRANCHED AND FENESTRATED THORACIC ENDOVASCULAR AORTIC REPAIR (B/FTEVAR) FROM 2020 TO 2022. THERE WERE 13 PATIENTS WITH 17 LASER FENESTRATIONS. AORTIC ENDOGRAFTS UTILIZED WERE ZENITH TX2 AND ALPHA TEVAR GRAFTS (COOK MEDICAL). MUSTANG HIGH-PRESSURE BALLOONS (BOSTON SCIENTIFIC) AND COVERED STENTS WITH GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS DEVICES WERE USED FOR FENESTRATIONS AND OSTIAL OPENINGS AND TECHNICAL SUCCESS WAS ACHIEVED IN ALL CASES. ADVERSE OUTCOMES INCLUDED INTRAOPERATIVE IDENTIFIED ENDOLEAK [TYPE II AND TYPE IIIC, BOTH TYPE IIIC ENDOLEAKS WERE FROM OTHER PREMODIFIED VISCERAL STENTS FOR THE AORTIC REPAIR THAT WERE NOT PERFORMED WITH THE LASER FENESTRATION] AND DEATH RELATED TO AORTIC REPAIR. SIX MONTHS POST PROCEDURE, THERE WERE TWO CASES OF TYPE IIIC ENDOLEAKS WHICH REQUIRED ADDITIONAL STENTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2819034 GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS ILIAC COVERED STENT, ARTERIAL PRL W. L. GORE & ASSOCIATES, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other