BEUDAMED
    FDA Adverse Event Death Summary report: N

    GORE VIABAHN ENDOPROSTHESIS WITH PROPATEN BIOACTIVE SURFACE

    MDR report key: 10708811 · Received October 20, 2020

    Report

    Report Number
    2017233-2020-01373
    Event Type
    Death
    Date Received
    October 20, 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

    ARTICLE 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.

    Additional Manufacturer Narrative · 0

    EVENT DESCRIPTION WAS UPDATED. 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: 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 1: THE PATIENT WAS IN HIS SEVENTIES AND HAD A HISTORY OF RADICAL RESECTION OF HYPOPHARYNGEAL CANCER. THE CANCER RECURRED NEAR THE RIGHT COMMON CAROTID ARTERY, AND RADIATION THERAPY WAS PERFORMED AGAIN. FROM THE END OF THE RADIATION THERAPY, A SKIN ULCER APPEARED ON THE RIGHT MANDIBLE. IMAGING SHOWED DISTANCE BETWEEN THE RIGHT COMMON CAROTID ARTERY AND THE SKIN ULCER BOTTOM WAS 3.6 MM, AND THE PATIENT WAS CONSIDERED THE HIGH RISK OF CAROTID BLOWOUT SYNDROME (CBS). THERE WAS NO OBVIOUS LOCAL RECURRENCE, AND IT WAS CONSIDERED THAT THE CAUSE OF THE ULCER WAS LATE RADIATION COMPLICATION. BECAUSE OF THE HIGH RISK OF CAROTID BLOWOUT SYNDROME (CBS), A GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (6 MM X 5 CM) WAS IMPLANTED IN THE RIGHT COMMON CAROTID ARTERY (DATE UNKNOWN). TWO (2) WEEKS AFTER THE IMPLANTATION, THE PATIENT DISCHARGED TO HOME. EIGHT (8) WEEKS AFTER THE IMPLANTATION, THE ULCER SUDDENLY INCREASED, AND THE STENT WAS EXPOSED TO BODY SURFACE. TISSUE BIOPSY CONFIRMED LOCAL RECURRENCE OF CANCER. THE PATIENT WAS THEN OBSERVED WITH BEST SUPPORTIVE CARE. FIFTEEN (15) WEEKS AFTER THE IMPLANTATION, THE PATIENT EXPIRED AT HOME DUE TO SEPSIS CAUSED BY LOCAL INFECTION. THERE WAS NO BLEEDING. THE PHYSICIANS STATED THE GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE IMPLANTATION WAS USEFUL AS THEY WERE ABLE TO PREVENT CAROTID BLOWOUT SYNDROME (CBS) IN TWO PATIENT. CUTANEOUS FISTULA, RESIDUAL TUMOR VOLUME AND STENT INFECTION DETERMINED THE PATIENTS¿ PROGNOSIS / OUTCOME. THEY ALSO CONSIDERED THAT ANTIPLATELET THERAPY SHOULD NOT BE STOPPED. THE LOCAL INFECTION CAUSED BY STENT EXPOSURE AFFECTED THE PATIENTS¿ PROGNOSIS/OUTCOME, AND IT WAS CONSIDERED THAT INFECTION CONTROL WAS IMPORTANT.

    Additional Manufacturer Narrative · 1

    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 TO GORE. THEREFORE, DIRECT PRODUCT ANALYSIS WAS NOT POSSIBLE. CASE 2 WAS REPORTED SEPARATELY IN MANUFACTURER REPORT NUMBER 2017233-2020-01365.

    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 VIABAHN IMPLANTATION AVOIDING VASCULAR RUPTURE. CASE 1: THE PATIENT WAS IN HIS SEVENTIES AND HAD A HISTORY OF RADICAL RESECTION OF HYPOPHARYNGEAL CANCER. THE CANCER RECURRED NEAR THE RIGHT COMMON CAROTID ARTERY, AND RADIATION THERAPY WAS PERFORMED AGAIN. HOWEVER, A SKIN ULCER APPEARED ON THE RIGHT MANDIBLE. BECAUSE OF THE HIGH RISK OF CAROTID BLOWOUT SYNDROME (CBS), A GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (6 MM X 5 CM) WAS IMPLANTED IN THE RIGHT COMMON CAROTID ARTERY ON AN UNKNOWN DATE. EIGHT (8) WEEKS AFTER THE IMPLANTATION, THE ULCER SUDDENLY INCREASED, AND THE STENT BECAME EXPOSED. FIFTEEN (15) WEEKS AFTER THE IMPLANTATION, THE PATIENT EXPIRED DUE TO SEPSIS. THE PHYSICIANS STATED THEY WERE ABLE TO PREVENT CAROTID BLOWOUT SYNDROME (CBS) IN THE PATIENT; HOWEVER, CUTANEOUS FISTULA, RESIDUAL TUMOR VOLUME AND STENT INFECTION DETERMINED THE PATIENT'S PROGNOSIS/OUTCOME. THEY ALSO CONSIDERED THAT ANTIPLATELET THERAPY SHOULD NOT BE STOPPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1172651 GORE VIABAHN ENDOPROSTHESIS WITH PROPATEN BIOACTIVE SURFACE SYSTEM, ENDO GRAFT, ARTERIOVENOUS DIALYSIS ACCESS CIRCUIT STENOSIS TREATMENT PFV W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death