BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE

    MDR report key: 19342959 · Received May 17, 2024

    Report

    Report Number
    2017233-2024-04943
    Event Type
    Injury
    Date Received
    May 17, 2024
    Date of Event
    December 1, 2022
    Report Date
    June 4, 2024
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    NIP
    PMA / PMN Number
    P040037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SNEH BRAHMBHATT, MBBS, LUIS F. ACOSTA, MD, GABY GABRIEL, MD, DRISS RAISSI, MD (2023). RECURRENT HEPATIC ARTERY PSEUDOANEURYSM REPAIR WITH OVERLAPPING TAPERED STENT-GRAFT TECHNIQUE. RADIOLOGY CASE REPORTS 18 (2023), 4537-4543. DOI: HTTPS://DOI.ORG/10.1016/J.RADCR.2023.09.038. CONCLUSION CODE D1001: THE REPORTED INFORMATION INCLUDED IN THE ARTICLE MENTIONS DEGRADATION OF THE ARTERIAL WALL IN THE TREATMENT AREA DUE TO PATIENT CONDITION. INFORMATION WAS OBTAINED THROUGH A PUBLICATION. 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. 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.

    Additional Manufacturer Narrative · 0

    SECTION C1: NAME: CBAS® HEPARIN SURFACE. MANUFACTURER/COMPOUNDER: W. L. GORE & ASSOCIATES, INC. SECTION D1: PRODUCT BRAND NAME UPDATED TO GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE. G3: UPDATED TO REFLECT 'COMBINATION PRODUCT' . CBAS® HEPARIN SURFACE INCORPORATES CARMEDA HEPARIN MANUFACTURED FROM HEPARIN SODIUM API, WHICH IS COVALENTLY BOUND TO THE DEVICE SURFACE AND IS ESSENTIALLY NON-ELUTING.

    Description of Event or Problem · 0

    IN (B)(6) 2022, A 57-YEAR-OLD MALE WITH A HISTORY OF SIGMOID COLON CANCER (RESECTION IN 2016) WAS REFERRED TO SURGICAL ONCOLOGY FOR CONSIDERATION OF HEPATIC ARTERY INFUSION PUMP [HAIP]. HE UNDERWENT HAIP PLACEMENT WITHOUT EVIDENCE OF IMMEDIATE COMPLICATIONS. IN (B)(6) 2022, THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT WITH WORSENING ABDOMINAL PAIN AND UNDERWENT A COMPUTED TOMOGRAPHY [CT] SCAN OF THE ABDOMEN. THE HAIP CATHETER TIP WAS FOUND TO BE DISLODGED. IT WAS NOTED THE INITIALLY PLACED HAIP CATHETER TIP, AT THE TAKEOFF OF THE GASTRODUODENAL ARTERY [GDA] FROM THE COMMON HEPATIC ARTERY, HAD FLOXURIDINE [FUDR] EXTRAVASATION ERODING FURTHER INTO THE INFERIOR ASPECT OF THE COMMON HEPATIC ARTERY. A 5 × 3 MM INFERIORLY ORIENTED FOCAL OUTPOUCHING IN THE COMMON HEPATIC ARTERY WAS NOTED, WHICH WAS SUSPICIOUS FOR A SMALL PSEUDOANEURYSM/PROMINENT GDA STUMP. EXTRAVASATION OF RADIOTRACER FROM THE DISTAL TIP OF THE HAIP ADJACENT TO ITS INITIAL INSERTION SITE INTO GDA STUMP, WITH ASSOCIATED FREE EXTRAVASATION INTO MULTIPLE LOCATIONS WITHIN THE ABDOMEN WAS ALSO FOUND. THE HAIP WAS REMOVED SURGICALLY FROM THE SUBCUTANEOUS POCKET, WHILE THE CATHETER PROXIMAL END WAS SUTURED TO THE POSTERIOR ASPECT OF THE LEFT RECTUS FASCIA. A 6 MM X 2.5 CM GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (VIABAHN® DEVICE) WAS SELECTED FOR COVERAGE ACROSS THE WALL DEFECT. IT WAS ALSO SUCCESSFULLY DEPLOYED WITH COMPLETE COVERAGE/RESOLUTION OF THE GDA STUMP/PSEUDOANEURYSM. 4 MONTHS LATER, FOLLOW-UP IMAGING SHOWED AN INCREASE IN THE SIZE OF THE COMMON HEPATIC ARTERY PSEUDOANEURYSM. THE PREVIOUSLY DEPLOYED COMMON HEPATIC ARTERY STENT WAS COMPLETELY EXTRALUMINAL IN RELATION TO THE COMMON HEPATIC ARTERY AS IT BECAME TOTALLY ENGULFED BY THE ENLARGING ANEURYSMAL SAC. THE PATIENT UNDERWENT AN ANGIOGRAM AND THE INITIAL DIGITAL SUBTRACTION ANGIOGRAM OF THE CELIAC ARTERY DEMONSTRATED A LARGE HEPATIC ARTERY PSEUDOANEURYSM WITH EXTRUSION AND COMPLETE ENGULFMENT OF THE STENT WITHIN THE ANEURYSMAL SAC AND SEVERE NARROWING OF THE COMMON AND PROPER HEPATIC ARTERIES. SUBSEQUENTLY, THE NARROWING WAS CROSSED, AND OVER THE WIRE, A 7 × 39 MM, A 6 × 39 MM, AND A 5 × 29 MM GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS DEVICES WERE OVERLAPPED AND DEPLOYED WITH COMPLETE EXCLUSION OF THE PSEUDOANEURYSM, WITHOUT EVIDENCE OF ENDOLEAK AFTER POST DEPLOYMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    920704 GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE STENT, SUPERFICIAL FEMORAL ARTERY NIP W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Male Hospitalization