BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® VIABAHN® ENDOPROSTHESIS WITH PROPATEN BIOACTIVE SURFACE

    MDR report key: 21697818 · Received March 26, 2025

    Report

    Report Number
    2017233-2025-05984
    Event Type
    Injury
    Date Received
    March 26, 2025
    Date of Event
    February 24, 2025
    Report Date
    June 27, 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

    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. ADDITIONALLY, NO ITEMS WERE RETURNED FOR EVALUATION (DEVICE, CLINICAL IMAGES). AS A RESULT, FURTHER INVESTIGATION COULD NOT BE PERFORMED AND THE INVESTIGATION IS COMPLETE. 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 INFORMATION WAS REQUESTED FROM THE AUTHOR OF THE LITERATURE ARTICLE, LIKE SERIAL NUMBER OF THE GORE DEVICES, IMPLANT DATES, DATE OF EVENT, PATIENT ID AND WEIGHT, BUT NO FURTHER INFORMATION WAS RECEIVED. IN THE INSTRUCTIONS FOR USE (IFU) FOR THE GORE® VIABAHN® ENDOPROSTHESIS PROPATEN BIOACTIVE SURFACE THE FOLLOWING IS STATED: ADVERSE EVENTS POSSIBLE ADVERSE EVENTS AND COMPLICATIONS THAT MAY OCCUR WITH THE USE OF ANY GORE® VIABAHN® ENDOPROSTHESIS WITH PROPATEN BIOACTIVE SURFACE OR IN ANY ENDOVASCULAR PROCEDURE AND REQUIRE INTERVENTION INCLUDE, BUT ARE NOT LIMITED TO (SHOWN IN ALPHABETICAL ORDER): OCCLUSION (THROMBOSIS AND/OR STENOSIS) OF ENDOPROSTHESIS OR VESSEL.

    Additional Manufacturer Narrative · 0

    B3: AS NO DATE RANGE WAS PROVIDED, THE DATE PUBLISHED FEBRUARY 24, 2025, WAS ENTERED AS THE DATE OF EVENT. 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, C20: THE SERIAL NUMBER REMAINS UNKNOWN, THEREFORE, A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE PERFORMED. H3, H6 CODES B21, C21, D16: THE DEVICE REMAINS IMPLANTED AND WAS, THEREFORE, NOT AVAILABLE FOR ANALYSIS. NO CLINICAL IMAGES ENABLING DIRECT ASSESSMENT OF PRODUCT PERFORMANCE WERE RETURNED FOR EVALUATION. THE AUTHOR OF THE LITERATURE ARTICLE WAS CONTACTED FOR FURTHER INFORMATION, INCLUDING SERIAL NUMBER, IMPLANT DATE, DATE OF EVENT, PATIENT ID AND WEIGHT. 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: FERNÁNDEZ ÁLVAREZ, I., FERNÁNDEZ LORENZO, J., VIDAL REY, J. AND ENCISA DE SÁ, J.M. (2025). INFECTED PARAVISCERAL ANEURYSM REPAIR WITH PARALLEL STENT GRAFTS. VASC SPE´C INT. 41, PP.1. DOI:10.5758/VSI.240093. THIS IS A TWO CASE REPORTS OF PATIENTS WITH INFECTED AORTIC ANEURYSMS. PATIENT (B)(6) IS CAPTURED IN THE CURRENT CASE (B)(4), PATIENT (B)(6) IS CAPTURED IN (B)(4). PATIENT (B)(6): A 76-YEAR-OLD MALE WITH HISTORY OF ORCHIEPIDIDYMITIS ONE YEAR PRIOR PRESENTED WITH LUMBAR PAIN AND LAB RESULTS WERE BENIGN. 10 DAYS LATER, HE WAS READMITTED WITH LEUKOCYTOSIS AND ELEVATED C-REACTIVE PROTEIN, URINE CULTURE SHOWED METHICILLIN-SENSITIVE STAPHYLOCOCCUS AUREUS (MSSA) GROWTH. AN ABDOMINAL COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) REVEALED SACCULAR ANEURYSM FROM THE CELIAC TRUNK (CT) TO THE SUPERIOR MESENTERIC ARTERY (SMA) SURROUNDED BY PERI-AORTIC COLLECTION AND MARKED INFLAMMATION CHANGES SUGGESTIVE OF IAA. BLOOD CULTURE WAS POSITIVE FOR MSSA AND SUBSEQUENT PET-CT REVEALED SIGNIFICANT PATHOLOGICAL HYPERMETABOLISM INDICATING INFECTIOUS PATHOLOGY IN THE SACCULAR ANEURYSM AND BETWEEN THE C6 AND C7 VERTEBRAE PROBABLY RELATED TO SPONDYLODISCITIS. EVAR WAS PERFORMED AND A GORE®TAG® CONFORMABLE THORACIC STENT GRAFT [37X100MM] WAS POSITIONED ABOVE THE RENAL ARTERIES AND GORE® VIABAHN® ENDOPROSTHESIS [9X150MM] WAS PLACED IN THE SMA AND GORE® VIABAHN® ENDOPROSTHESIS [9X100MM] AND GORE® VIABAHN® ENDOPROSTHESIS [9X50MM] WERE PLACED IN THE CT AND IN THE SMA AND CT AND INTERNALLY REINFORCED WITH 9×100 MM AND 9×60 MM ABSOLUTE PRO SELF-EXPANDING STENTS, RESPECTIVELY. FINAL ANGIOGRAPHY SHOWED EXCLUSION OF THE ANEURYSM WITHOUT ENDOLEAKS AND PATENCY OF THE SMA AND CT. INTRAOPERATIVE BLOOD CULTURES SHOWED MSSA GROWTH. THREE DAYS AFTER DISCHARGE, THE PATIENT RETURNED WITH ABDOMINAL DISCOMFORT AND NAUSEA. FOLLOW UP CTA REVEALED FINDINGS SUSPICIOUS FOR TYPE III ENDOLEAK AND ANGIOGRAPHY REVEALED TYPE1B ENDOLEAK. BALLOON ANGIOPLASTY WAS PERFORMED; HOWEVER, ENDOLEAK PERSISTED IN THE DISTAL PART OF THE THORACIC ENDOGRAFT. DISTAL SEAL WAS EXTENDED USING TWO AORTIC GRAFTS- (C-TAG, GORE MEDICAL; 28×100 MM AND 34×100 MM) AND BALLOON-EXPANDABLE STENT GRAFTS (VIABAHN VBX BALLOON EXPANDABLE ENDOPROSTHESIS, GORE MEDICAL; 6×79 MM AND 7×79 MM) IN THE RIGHT AND LEFT RENAL ARTERIES, RESPECTIVELY. THE TYPE 1B ENDOLEAK WAS RESOLVED BUT SMALL CONTRAST EXTRAVASATION WAS VISIBLE CONSISTENT WITH TYPE II ENDOLEAK WHICH WAS MANAGED WITH FOLLOW UP CTA FOR MONITORING. 24 MONTHS AFTER SECOND PROCEDURE, THERE WAS NO ENDOLEAK IN THE SMA AND CT BUT THERE WAS FILLING OF THE ANEURYSMAL SAC VIA TWO INTERCOSTAL ARTERIES [ENDOLEAK TYPE II]. COILS WERE DEPLOYED AND ENDOLEAK WAS RESOLVED AND CT AND SMA WERE PATENT. 33 MONTHS AFTER SECOND PROCEDURE, FOLLOW UP CTA CONFIRMED ANEURYSM EXCLUSION WITHOUT ENDOLEAKS. AN ASYMPTOMATIC SMA STENT THROMBOSIS WAS OBSERVED WITH DISTAL SMA FLOW MAINTAINED THROUGH COLLATERAL BRANCHES SO NO FURTHER INTERVENTIONS WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1100676 GORE® VIABAHN® ENDOPROSTHESIS WITH PROPATEN BIOACTIVE SURFACE STENT, SUPERFICIAL FEMORAL ARTERY NIP W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male