BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE

    MDR report key: 24854542 · Received April 13, 2026

    Report

    Report Number
    2017233-2026-07363
    Event Type
    Injury
    Date Received
    April 13, 2026
    Date of Event
    October 17, 2025
    Report Date
    April 13, 2026
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    NIP
    PMA / PMN Number
    P040037
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    HEPARIN SURFACE INCORPORATES CARMEDA HEPARIN MANUFACTURED FROM HEPARIN SODIUM API, WHICH IS COVALENTLY BOUND TO THE DEVICE SURFACE AND IS ESSENTIALLY NON-ELUTING. A1: NO PATIENT SPECIFIC DETAILS HAVE BEEN PROVIDED. THEREFORE, THE PATIENT INITIALS REFLECT THE W. L. GORE INTERNAL CASE NUMBER. H6: A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE COULD NOT BE PERFORMED AS A VALID LOT NUMBER WAS NOT PROVIDED. LITERATURE TITLE: CEFEPIME-INDUCED ENCEPHALOPATHY FOLLOWING PANCREATICODUODENECTOMY: A CASE REPORT OF A RARE POSTOPERATIVE COMPLICATION IN GASTROINTESTINAL SURGERY SOURCE: CLINICAL JOURNAL OF GASTROENTEROLOGY (2026) 19:100¿105. 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 PUBLISHMENT WAS REVIEWED BY GORE: TITLE: CEFEPIME-INDUCED ENCEPHALOPATHY FOLLOWING PANCREATICODUODENECTOMY: A CASE REPORT OF A RARE POSTOPERATIVE COMPLICATION IN GASTROINTESTINAL SURGERY SOURCE: CLINICAL JOURNAL OF GASTROENTEROLOGY (2026) 19:100¿105. THIS CASE REPORT DESCRIBES A RARE POSTOPERATIVE COMPLICATION OF CEFEPIME-INDUCED ENCEPHALOPATHY (CE) FOLLOWING PANCREATICODUODENECTOMY FOR A DISTAL BILE DUCT TUMOR. THE PURPOSE OF THE STUDY WAS TO HIGHLIGHT THE CLINICAL PRESENTATION AND MANAGEMENT OF CE, A KNOWN BUT OFTEN UNDERRECOGNIZED ADVERSE EFFECT OF CEFEPIME. THE STUDY INVOLVES AN 83-YEAR-OLD FEMALE WHO UNDERWENT PANCREATICODUODENECTOMY FOR A DISTAL BILE DUCT TUMOR. ON POSTOPERATIVE DAY (POD) 6, SHE DEVELOPED A PSEUDOANEURYSM OF THE COMMON HEPATIC ARTERY CAUSED BY A POSTOPERATIVE PANCREATIC FISTULA, WHICH WAS TREATED WITH INTERVENTIONAL RADIOLOGY USING A GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (VSX DEVICE) PLACED FROM THE CELIAC ARTERY (CA) TO THE COMMON HEPATIC ARTERY (CHA). LIVER FAILURE DEVELOPED THE FOLLOWING DAY, AND ANGIOGRAPHY REVEALED OCCLUSION OF THE CA CAUSED BY A KINKED VSX DEVICE. THE PATIENT IMMEDIATELY UNDERWENT PLACEMENT OF AN ADDITIONAL OVERLAPPING VSX DEVICE, RESTORING FLOW. THE PATIENT LATER DEVELOPED A LIVER ABSCESS ON POD 15, REQUIRING DRAINAGE AND PROLONGED ANTIMICROBIAL THERAPY. ON POD 47, MULTIDRUG-RESISTANT PSEUDOMONAS AERUGINOSA (MDRP) WAS IDENTIFIED IN A DRAIN CULTURE, PROMPTING ADJUSTMENT OF ANTIBIOTIC THERAPY. THE PANCREATOENTERIC DRAIN WAS REMOVED ON POD 122, FOLLOWED BY REMOVAL OF THE LIVER ABSCESS DRAIN ON POD 153. THE PATIENT WAS DISCHARGED HOME ON POD 260. SHE HAS REMAINED RECURRENCE-FREE AND CONTINUES OUTPATIENT FOLLOW-UP AT 4 YEARS AND 10 MONTHS POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    922293 GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE STENT, SUPERFICIAL FEMORAL ARTERY NIP W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Female Required Intervention