BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® VIABAHN® ENDOPROSTHESIS WITH PROPATEN BIOACTIVE SURFACE

    MDR report key: 22542237 · Received July 18, 2025

    Report

    Report Number
    2017233-2025-06428
    Event Type
    Injury
    Date Received
    July 18, 2025
    Date of Event
    August 19, 2019
    Report Date
    September 19, 2025
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    NIP
    PMA / PMN Number
    P040037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6, CODE A27: A27 WAS USED TO DESCRIBE "DEVICE REMOVED". H3 OTHER; H6 CODES B18, C20, D15, D1001: A UNIQUE DEVICE IDENTIFICATION NUMBER WAS NOT PROVIDED; THEREFORE, THE MANUFACTURING DATE AND/OR PRODUCTION DETAILS CANNOT BE DETERMINED. NEITHER CLINICAL IMAGES ENABLING DIRECT ASSESSMENT OF PRODUCT PERFORMANCE NOR THE PRODUCT ITSELF WERE RETURNED FOR EVALUATION. THE CAUSE OF THE REPORTED THROMBOSIS COULD NOT BE ESTABLISHED. BASED ON THE INFORMATION AVAILABLE, THE DECISION TO REMOVE THE VSX DEVICE WAS RELATED TO THE PATIENT CONDITION ([INFECTION] SYMPTOM CHRONIFICATION LED TO EXPOSURE OF THE PROSTHESIS). 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.

    Additional Manufacturer Narrative · 0

    A1: NO PATIENT SPECIFIC DETAILS HAVE BEEN PROVIDED. THEREFORE, THE PATIENT INITIALS REFLECT THE W. L. GORE INTERNAL CASE NUMBER.) 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, CODE A27: A27 WAS USED TO DESCRIBE "ENDOPROSTHESIS BECOMING EXTERNALLY EXPOSED OR VISIBLE". H6 CODES B14, C21: THE INVESTIGATION IS ONGOING. PRELIMINARY RESULTS ARE NOT YET AVAILABLE. H3 OTHER; H6 CODES B21, C21: ADDITIONAL INFORMATION WAS REQUESTED FROM THE CORRESPONDING AUTHOR. 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 ARTICLE WAS REVIEWED: BLANCO-RUIZ M, FERNÁNDEZ-PÉREZ J, YOLDI R, RODRÍGUEZ R, ARJONA-PADILLO A. PSEUDOANEURYSM AND PROSTHETIC EXPOSURE: AN EXCEPTIONAL COMPLICATION OF ENDARTERECTOMY AND CAROTID ANGIOPLASTY. NEUROL PERSPECT. 2024;4(2):100151. DOI:10.1016/J.NEUROP.2024.100151 THIS IS A CASE REPORT OF A 65-YEAR-OLD MAN WITH HISTORY OF CERVICAL RADIOTHERAPY TO TREAT GLOTTIC CARCINOMA 35 YEARS EARLIER AND ENDARTERECTOMY USING A DACRON PATCH DUE TO ASYMPTOMATIC 90% STENOSIS OF THE RIGHT INTERNAL CAROTID ARTERY (ICA). TEN YEARS LATER, FOLLOWING A BIOPSY OF THE CERVICAL REGION DUE TO ADENOPATHY SUGGESTIVE OF MALIGNANCY, WHICH FINALLY REVEALED CHRONIC INFLAMMATION DUE TO A FOREIGN BODY, THE PATIENT PRESENTED A POLYMICROBIAL INFECTION TOGETHER WITH A SKIN FISTULA. A CT ANGIOGRAPHY STUDY REVEALED A PSEUDOANEURYSM IN THE RIGHT ICA, WHICH WAS TREATED WITH ANGIOPLASTY AND THE PLACEMENT OF A GORE® VIABAHN® ENDOPROSTHESIS WITH PROPATEN BIOACTIVE SURFACE (VIABAHN STENT). THE INFECTION AND FISTULA BECAME CHRONIC, AND THE VIABAHN STENT WAS EXPOSED. OCCLUSION OF THE PSEUDOANEURYSM WAS PROPOSED AFTER A COMPATIBLE OCCLUSION TEST BUT WAS NOT FINALLY PERFORMED DUE TO SPONTANEOUS THROMBOSIS OF THE VIABAHN STENT IN THE RIGHT ICA, RESULTING IN TRANSIENT ISCHEMIC ATTACK IN THE RIGHT HEMISPHERE AS THE ONLY NEUROLOGICAL SYMPTOM. ONE YEAR AFTER THE PREVIOUS EVENT, THE VIABAHN STENT WAS REMOVED. IT WAS NOTED THAT THE DEVELOPMENT OF THE PSEUDOANEURYSM WAS SECONDARY TO INFECTION, WHICH WAS CAUSED BY A NECK BIOPSY. ON (B)(6) 2025, THE CORRESPONDING AUTHOR PROVIDED FOLLOWING ADDITIONAL INFORMATION ON REQUEST: THE PATIENT HAD A HISTORY OF LARYNGEAL CANCER TREATED WITH RADIOTHERAPY IN 1986. SUBSEQUENTLY, THE PATIENT DEVELOPED AN ASYMPTOMATIC STENOSIS OF THE RIGHT ICA, FOR WHICH A PREVENTIVE ENDARTERECTOMY WAS PERFORMED IN 2005. BETWEEN 2012 AND 2013, A CERVICAL MASS WAS BIOPSIED AND COMPLICATED BY CHRONIC INFECTION WITH FISTULA FORMATION COMMUNICATING WITH THE CAROTID ARTERY, ASSOCIATED WITH BLEEDING DUE TO SUTURE DEHISCENCE AND PSEUDOANEURYSM FORMATION. ON (B)(6) 2015, TO ADDRESS THIS CONDITION, A VIABAHN STENT WAS PLACED. IN 2019, THE CHRONIC INFECTION PERSISTED WITH EXTERNAL EXPOSURE OF THE STENT, WHICH ALSO BECAME OCCLUDED ON (B)(6) 2019, RESULTING IN PERMANENT VISION LOSS IN THE RIGHT EYE. IN 2021, THE CHRONIC INFECTION CONTINUED, LEADING TO THE DECISION TO REMOVE THE VIABAHN STENT. ON (B)(6) 2021, THE VIABAHN STENT WAS EXPLANTED DUE TO THE CHRONIC RIGHT CERVICAL WOUND AND THE OCCLUSION. THE VIABAHN STENT WAS DISCARDED BY THE HOSPITAL. THE WOUND SUBSEQUENTLY HEALED.

    Description of Event or Problem · 0

    THE FOLLOWING ARTICLE WAS REVIEWED: BLANCO-RUIZ M, FERNÁNDEZ-PÉREZ J, YOLDI R, RODRÍGUEZ R, ARJONA-PADILLO A. PSEUDOANEURYSM AND PROSTHETIC EXPOSURE: AN EXCEPTIONAL COMPLICATION OF ENDARTERECTOMY AND CAROTID ANGIOPLASTY. NEUROL PERSPECT. 2024;4(2):100151. DOI:10.1016/J.NEUROP.2024.100151. THIS IS A CASE REPORT OF A 65-YEAR-OLD MAN WITH HISTORY OF CERVICAL RADIOTHERAPY TO TREAT GLOTTIC CARCINOMA 35 YEARS EARLIER AND ENDARTERECTOMY USING A DACRON PATCH DUE TO ASYMPTOMATIC 90% STENOSIS OF THE RIGHT INTERNAL CAROTID ARTERY (ICA). TEN YEARS LATER, FOLLOWING A BIOPSY OF THE CERVICAL REGION DUE TO ADENOPATHY SUGGESTIVE OF MALIGNANCY, WHICH FINALLY REVEALED CHRONIC INFLAMMATION DUE TO A FOREIGN BODY, THE PATIENT PRESENTED A POLYMICROBIAL INFECTION TOGETHER WITH A SKIN FISTULA. A CT ANGIOGRAPHY STUDY REVEALED A PSEUDOANEURYSM IN THE RIGHT ICA, WHICH WAS TREATED WITH ANGIOPLASTY AND THE PLACEMENT OF A GORE® VIABAHN® ENDOPROSTHESIS (VIABAHN DEVICE). THE INFECTION AND FISTULA BECAME CHRONIC, AND THE VIABAHN DEVICE WAS EXPOSED. OCCLUSION OF THE PSEUDOANEURYSM WAS PROPOSED AFTER A COMPATIBLE OCCLUSION TEST BUT WAS NOT FINALLY PERFORMED DUE TO SPONTANEOUS THROMBOSIS OF THE VIABAHN DEVICE IN THE RIGHT ICA, RESULTING IN TRANSIENT ISCHEMIC ATTACK IN THE RIGHT HEMISPHERE AS THE ONLY NEUROLOGICAL SYMPTOM. ONE YEAR AFTER THE PREVIOUS EVENT, THE VIABAHN DEVICE WAS REMOVED. IT WAS NOTED THAT THE DEVELOPMENT OF THE PSEUDOANEURYSM WAS SECONDARY TO INFECTION, WHICH WAS CAUSED BY A NECK BIOPSY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1196468 GORE® VIABAHN® ENDOPROSTHESIS WITH PROPATEN BIOACTIVE SURFACE STENT, SUPERFICIAL FEMORAL ARTERY NIP W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male Other ASPIRIN (ACETYLSALICYLIC ACID)| ATORVASTATIN| LEVOTHYROXINE| METFORMIN| NEBIVOLOL| OLMESARTAN| SILODOSIN