BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® VIABAHN® ENDOPROSTHESIS

    MDR report key: 25327094 · Received May 29, 2026

    Report

    Report Number
    2017233-2026-07565
    Event Type
    Injury
    Date Received
    May 29, 2026
    Date of Event
    March 8, 2025
    Report Date
    May 29, 2026
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    NIP
    PMA / PMN Number
    P040037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ARTICLE CITATION: XU Y, YANG W, LI X, WANG X, PAN D, YUAN Z, HAN L, HUANG K, DING Z, WU Z, QIU C, WANG X. ENDOVASCULAR TREATMENT AND HYBRID SURGERY FOR EXTRACRANIAL INTERNAL CAROTID ARTERY ANEURYSMS. ANN VASC SURG. 2025;115:206-216. DOI:10.1016/J.AVSG.2025.02.022 PUBLISHED ONLINE: 8 MARCH 2025. A1: NO PATIENT SPECIFIC DETAILS HAVE BEEN PROVIDED. THEREFORE, THE PATIENT INITIALS REFLECT THE W. L. GORE INTERNAL CASE NUMBER. C1: CBAS® HEPARIN SURFACE INCORPORATES CARMEDA HEPARIN MANUFACTURED FROM HEPARIN SODIUM API, WHICH IS COVALENTLY BOUND TO THE DEVICE SURFACE AND IS ESSENTIALLY NON-ELUTING. H6: CODE D15 - A UNIQUE DEVICE IDENTIFICATION NUMBER WAS NOT PROVIDED; THEREFORE, THE MANUFACTURING DATE AND/OR PRODUCTION DETAILS CANNOT BE DETERMINED. NEITHER CLINICAL IMAGES ENABLING ASSESSMENT OF PRODUCT PERFORMANCE NOR THE PRODUCT ITSELF WERE RETURNED FOR EVALUATION, THE INVESTIGATION COULD NOT BE PERFORMED. THE AVAILABLE INFORMATION REPORTED IN THE COMPLAINT DOES NOT REASONABLY SUGGEST A POTENTIAL MALFUNCTION OR PRODUCT PACKAGING AND/OR LABELING ISSUE HAS OCCURRED. THE REPORTED COMPLICATION REPRESENTS A KNOWN COMPLICATION OR ADVERSE EVENT THAT CAN OCCUR WHEN USING STENT-GRAFT ENDOVASCULAR DEVICES AND CAN ARISE AS A RESULT OF A MULTITUDE OF FACTORS, INCLUDING INTRAPROCEDURAL TECHNICAL CONSIDERATIONS, POST-OPERATIVE FOLLOW UP AND TREATMENT REGIMEN, PATIENT-RELATED RISK FACTORS AND DISEASE PROGRESSION. NO ALLEGATION OF DEVICE MALFUNCTION, SUCH AS STENT COLLAPSE OR STRUCTURAL DEFORMATION WAS INDICATED WITH RESPECT TO DEVICE PERFORMANCE. 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 INFORMATION WAS RECEIVED THROUGH LITERATURE: ENDOVASCULAR TREATMENT AND HYBRID SURGERY FOR EXTRACRANIAL INTERNAL CAROTID ARTERY ANEURYSMS. ANN VASC SURG. 2025;115:206-216. THIS RETROSPECTIVE SINGLE-CENTER STUDY EVALUATED THE OUTCOMES OF ENDOVASCULAR TREATMENT AND HYBRID SURGERY FOR EXTRACRANIAL INTERNAL CAROTID ARTERY ANEURYSMS [EICAAS] TREATED BETWEEN JANUARY 2013 AND JUNE 2023. THE STUDY INCLUDED 28 PATIENTS [MEAN AGE 61 YEARS OLD, 21 MALES] WITH 30 EICAAS WHO UNDERWENT EITHER ENDOVASCULAR TREATMENT OR HYBRID SURGERY BETWEEN JANUARY 2013 AND JULY 2023. FIFTEEN TRUE ANEURYSMS AND FIFTEEN PSEUDOANEURYSMS WERE IDENTIFIED. FIFTEEN ANEURYSMS WERE TREATED WITH ENDOVASCULAR TECHNIQUES AND FIFTEEN WITH HYBRID SURGERY. COVERED STENTS, INCLUDING GORE® VIABAHN® STENTS, BARE METAL STENTS WITH COIL EMBOLIZATION, OR COMBINATIONS OF THESE APPROACHES WERE USED DEPENDING ON ANEURYSM ANATOMY AND LESION COMPLEXITY. A 61-YEAR-OLD MALE PATIENT TREATED WITH A 5 X50 MM GORE® VIABAHN® COVERED STENT EXPERIENCED DISTAL ENDOLEAK IMMEDIATELY FOLLOWING COVERED STENT DEPLOYMENT, REQUIRING PLACEMENT OF TWO ADDITIONAL BARE METAL STENTS AND COIL EMBOLIZATION. HE EXPERIENCED A MINOR STROKE THE DAY AFTER SURGICAL INTERVENTION THAT PRESENTED AS PARALYSIS OF THE RIGHT HAND AND TONGUE EXTENSION THAT DEVIATED TO THE RIGHT. THE SYMPTOMS OF HIS STROKE RESOLVED AFTER 5 DAYS OF ANTIPLATELET TREATMENT. AT 12-MONTH FOLLOW-UP, HE DEVELOPED IN-STENT RESTENOSIS (70%, 20 MM) ASSOCIATED WITH MINOR IPSILATERAL STROKE SYMPTOMS AND SHOWED IMPROVEMENT IN SYMPTOMS AFTER UNDERGOING BALLOON ANGIOPLASTY REINTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    102708 GORE® VIABAHN® ENDOPROSTHESIS STENT, SUPERFICIAL FEMORAL ARTERY NIP W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1