BEUDAMED
    FDA Adverse Event Death Summary report: N

    GORE VIABAHN ENDOPROSTHESIS WITH PROPATEN BIOACTIVE SURFACE

    MDR report key: 10698237 · Received October 19, 2020

    Report

    Report Number
    2017233-2020-01365
    Event Type
    Death
    Date Received
    October 19, 2020
    Date of Event
    October 8, 2020
    Report Date
    November 13, 2020
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    PFV
    PMA / PMN Number
    P040037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    EVENT DESCRIPTION WAS UPDATED WITH SECOND ARTICLE RECEIVED. SOURCE ATTACHED: TWO CASES OF VIABAHN IMPLANTATION FOR LOCALLY ADVANCED RECURRENT HEAD AND NECK CANCER WITH A COMMON CAROTID ARTERY INFILTRATION, THE OFFICIAL JOURNAL OF THE JAPANESE SOCIETY OF INTERVENTIONAL RADIOLOGY, 2020: 35 (SUPPLEMENTAL) P.266-267.

    Description of Event or Problem · 0

    THE FOLLOWING PUBLICATIONS WERE REVIEWED, AND INFORMATION WAS COMBINED: SOURCE: TWO CASES OF POSTOPERATIVE RECURRENCE OF HEAD AND NECK CANCER AND CAROTID ARTERY INFILTRATION TREATED WITH VIABAHN IMPLANTATION AVOIDING VASCULAR RUPTURE, THE OFFICIAL JOURNAL OF THE JAPANESE SOCIETY OF INTERVENTIONAL RADIOLOGY, 2020: 34(4) P.297. SOURCE: TWO CASES OF VIABAHN IMPLANTATION FOR LOCALLY ADVANCED RECURRENT HEAD AND NECK CANCER WITH A COMMON CAROTID ARTERY INFILTRATION, THE OFFICIAL JOURNAL OF THE JAPANESE SOCIETY OF INTERVENTIONAL RADIOLOGY, 2020: 35(SUPPLEMENTAL) P.266-267. CASE 2: THE PATIENT WAS IN HER SEVENTIES WITH A HISTORY OF THYROID CANCER SURGERY AND RADIATION THERAPY. OVER TEN YEARS AFTER THE INITIAL SURGERY, CANCER RECURRED ON THE FRONT NECK, AND LENVIMA WAS ADMINISTERED. LATER, THE TUMOR DISRUPTED, AND A TRACHEO-CUTANEOUS FISTULA AND A TRACHEAL ULCER DEVELOPED. A PSEUDOANEURYSM DEVELOPED IN THE RIGHT COMMON CAROTID ARTERY WHICH WAS NEAR THE TUMOR AREA. A GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (6 MM X 5 CM) WAS IMPLANTED TO COVER THE ULCER. FOURTEEN (14) DAYS AFTER THE IMPLANTATION, ANTIPLATELET MEDICATION NEEDED TO BE STOPPED IN ORDER TO RESTART THE LENVIMA. AFTER THAT, TISSUE DEFECT IN THE FRONT NECK WAS ENLARGED DUE TO TUMOR DISRUPTION, AND THE VIABAHN DEVICE WAS EXPOSED TO THE TRACHEAL SIDE AND THE BODY SURFACE. TWENTY-FOUR DAYS AFTER THE IMPLANTATION, VIABAHN DEVICE INFECTION AND OCCLUSION OCCURRED, AND THE RIGHT CEREBRAL INFARCTION DEVELOPED. NO MAJOR BLEEDING OCCURRED; HOWEVER, THE TRACHEO-CUTANEOUS FISTULA CONTINUED TO EXPAND. SIXTY-FOUR (64) DAYS AFTER THE IMPLANTATION, THE PATIENT EXPIRED AT THE HOSPITAL DUE TO SEPSIS. THE PHYSICIANS STATED GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE IMPLANTATION WAS USEFUL AS THEY WERE ABLE TO PREVENT CAROTID BLOWOUT SYNDROME (CBS) IN THE TWO PATIENTS. HOWEVER, LOCAL INFECTION CAUSED BY STENT EXPOSURE AFFECTED THE PATIENTS¿ PROGNOSIS/OUTCOME. CUTANEOUS FISTULA, RESIDUAL TUMOR VOLUME AND STENT INFECTION DETERMINED THE PATIENTS¿ PROGNOSIS/OUTCOME. THE PHYSICIANS ALSO CONSIDERED THAT ANTIPLATELET THERAPY SHOULD NOT BE STOPPED.

    Additional Manufacturer Narrative · 1

    PUBLICATION SOURCE: TWO CASES OF POSTOPERATIVE RECURRENCE OF HEAD AND NECK CANCER AND CAROTID ARTERY INFILTRATION TREATED WITH VIABAHN IMPLANTATION AVOIDING VASCULAR RUPTURE, THE OFFICIAL JOURNAL OF THE JAPANESE SOCIETY OF INTERVENTIONAL RADIOLOGY, 2020: 34(4) P.297. CBAS® HEPARIN SURFACE INCORPORATES CBAS-HEPARIN MANUFACTURED FROM HEPARIN SODIUM API, WHICH IS COVALENTLY BOUND TO THE DEVICE SURFACE AND IS ESSENTIALLY NON-ELUTING. DEVICE LOT/SERIAL NUMBER WAS REQUESTED BUT NOT MADE AVAILABLE; DEVICE WAS NOT RETURNED; THEREFORE, DIRECT ANALYSIS WAS NOT POSSIBLE.

    Description of Event or Problem · 1

    THE FOLLOWING PUBLICATION WAS REVIEWED: TWO CASES OF POSTOPERATIVE RECURRENCE OF HEAD AND NECK CANCER AND CAROTID ARTERY INFILTRATION TREATED WITH A VIABAHN IMPLANTATION AVOIDING VASCULAR RUPTURE CASE 2: THE PATIENT WAS IN HER SEVENTIES WITH A HISTORY OF THYROID CANCER SURGERY. TEN YEARS AFTER THE INITIAL SURGERY, CANCER RECURRED ON THE FRONT NECK, AND LENVIMA WAS ADMINISTERED. THE TUMOR DISRUPTED, AND A TRACHEAL ULCER DEVELOPED. AS THE ULCER WAS NEAR THE RIGHT COMMON CAROTID ARTERY, A GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (6 MM X 5 CM) WAS IMPLANTED TO COVER THE ULCER. FOURTEEN DAYS AFTER THE IMPLANTATION, ANTIPLATELET MEDICATION WAS STOPPED TO RESTART THE LENVIMA. AFTER THAT, THE VIABAHN DEVICE WAS EXPOSED TO THE TRACHEAL SIDE AND 24 DAYS AFTER THE IMPLANTATION, VIABAHN DEVICE INFECTION AND OCCLUSION OCCURRED. AFTER THAT A TRACHEO-CUTANEOUS FISTULA CONTINUED TO EXPAND AS WELL, AND 64 DAYS AFTER THE IMPLANTATION, THE PATIENT EXPIRED DUE TO SEPSIS. THE ARTICLE STATED THE PHYSICIANS WERE ABLE TO PREVENT CAROTID BLOWOUT SYNDROME (CBS) IN THE TWO PATIENTS; HOWEVER, CUTANEOUS FISTULA, RESIDUAL TUMOR VOLUME AND STENT INFECTION DETERMINED THE PATIENTS¿ PROGNOSIS/OUTCOME. THEY ALSO CONSIDERED THAT ANTIPLATELET THERAPY SHOULD NOT BE STOPPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1163451 GORE VIABAHN ENDOPROSTHESIS WITH PROPATEN BIOACTIVE SURFACE STENT, SUPERFICIAL FEMORAL ARTERY PFV W. L. GORE & ASSOCIATES, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death| O