BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE

    MDR report key: 21080082 · Received January 6, 2025

    Report

    Report Number
    2017233-2025-05690
    Event Type
    Injury
    Date Received
    January 6, 2025
    Date of Event
    August 16, 2024
    Report Date
    January 6, 2025
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    NIP
    PMA / PMN Number
    P040037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CBAS® HEPARIN SURFACE INCORPORATES CARMEDA HEPARIN MANUFACTURED FROM HEPARIN SODIUM API, WHICH IS COVALENTLY BOUND TO THE DEVICE SURFACE AND IS ESSENTIALLY NON-ELUTING. B20 AND B22: DETAILS WERE REQUESTED FROM THE AUTHOR MULTIPLE TIMES. AS OF TODAY, NO RESPONSE HAS BEEN RECEIVED. THEREFORE, NO DEVICE LOT/SERIAL NUMBER WAS AVAILABLE FOR REVIEW OF DEVICE HISTORY. THE ARTICLE INDICATES AN ADDITIONAL DEVICE WAS IMPLANTED WITH NO MENTION OF AN EXPLANTED DEVICE. THEREFORE, IT WAS CONCLUDED THE DEVICE REMAINS IMPLANTED. PUBLICATION REVIEWED: POST NECK RADIATION CANCER CAROTID PSEUDOANEURYSM BLOWOUTS WITH VIABAHN STENT PLACEMENT. AUTHORS: MRINALINI PATIL MD, BAILEY N. HASSMAN MD, DANIEL JOHNSON MD, JONATHAN R. THOMPSON MD, JAYME DOWDALL MD, JASON R. COOK MD PHD. ANNALS OF VASCULAR SURGERY (ACCEPTED DATE 16 AUGUST 2024, WHICH WAS USED AS EVENT DATE). 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

    JOURNAL PRE-PROOF REVIEWED: POST NECK RADIATION CANCER CAROTID PSEUDOANEURYSM BLOWOUTS WITH VIABAHN STENT PLACEMENT. AUTHORS: MRINALINI PATIL MD, BAILEY N. HASSMAN MD, DANIEL JOHNSON MD, JONATHAN R. THOMPSON MD, JAYME DOWDALL MD, JASON R. COOK MD PHD. ANNALS OF VASCULAR SURGERY (ACCEPTED 16 AUGUST 2024). TWO PATIENTS WITH CAROTID BLOWOUT SYNDROME (CBS) WERE TREATED WITH GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (VIABAHN® DEVICE). IN ONE CASE, A 73-YEAR-OLD MALE PATIENT WAS TREATED WITH A 8 MM X 5 CM VIABAHN® DEVICE, WITH DEPLOYMENT ACROSS THE RIGHT CAROTID BIFURCATION TO EXCLUDE A DISTAL RIGHT COMMON CAROTID ARTERY PSEUDOANEURYSM. THE PATIENT WAS DISCHARGED HOME ON POST OP DAY 3 WITH A ONE-WEEK COURSE OF UNASYN TO ADDRESS POTENTIAL FISTULOUS CONNECTION CONCERNS. SIX MONTHS POST IMPLANT, THE PATIENT DEVELOPED PSEUDOMONAL BACTEREMIA, WITH PET/CT SHOWING INCREASED AVIDITY AROUND THE RIGHT COMMON CAROTID ARTERY AND VIABAHN DEVICE, SUGGESTIVE OF INFECTION. A RECURRENCE OF THE RIGHT COMMON CAROTID ARTERY PSEUDOANEURYSM WAS NOTED SIX MONTHS POSTOPERATIVELY NECESSITATING PLACEMENT OF AN ADDITIONAL GORE® VIABAHN® ENDOPROSTHESIS FOR PALLIATION. THE SECOND CASE REPORTED NO ADVERSE EVENTS. A 56-YEAR-OLD MALE PATIENT WAS TREATED WITH A 11MM X 5CM GORE® VIABAHN® ENDOPROSTHESIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1137802 GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE STENT, SUPERFICIAL FEMORAL ARTERY NIP W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male Required Intervention