BEUDAMED
    FDA Adverse Event Death Summary report: N

    GORE VIABAHN ENDOPROSTHESIS - 3

    MDR report key: 10120833 · Received June 4, 2020

    Report

    Report Number
    2017233-2020-00401
    Event Type
    Death
    Date Received
    June 4, 2020
    Date of Event
    February 1, 2020
    Report Date
    July 10, 2020
    Manufacturer
    W.L. GORE & ASSOCIATES
    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

    CORRECTED DATA: B5. - DESCRIBE EVENT OR PROBLEM. H6. - CONCLUSIONS CODE 1. ADDITIONAL MANUFACTURER NARRATIVE: REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE COMPLETED AS NO LOT NUMBER INFORMATION WAS PROVIDED. THE DEVICE WAS NOT RETURNED. CONSEQUENTLY, A DIRECT PRODUCT ANALYSIS WAS NOT POSSIBLE. ADDITIONAL INFORMATION ABOUT THIS EVENT COULD NOT BE OBTAINED. AS A RESULT, NO FURTHER INVESTIGATION IS POSSIBLE. ALL INFORMATION HAS BEEN PLACED ON FILE FOR USE IN TRACKING AND TRENDING.

    Additional Manufacturer Narrative · 0

    ADDITIONAL MANUFACTURER NARRATIVE: A2. AGE AT TIME OF EVENT (NO ACTUAL PATIENT AGE WAS PROVIDED. THEREFORE, PATIENT AGE IS AN ESTIMATE BASED ON INITIAL INFORMATION.) B3. DATE OF EVENT (NO ACTUAL EVENT DATE WAS PROVIDED. THEREFORE, DATE OF EVENT IS AN ESTIMATE BASED ON THE INITIAL INFORMATION PROVIDED.) CORRECTED DATA: E1. NAME AND ADDRESS.

    Description of Event or Problem · 0

    THE FOLLOWING PUBLICATION WAS REVIEWED: "INITIAL EXPERIENCE OF VIABAHN AT THE FACILITY"; JAPANESE JOURNAL OF RADIOLOGY; VOLUME 38; SUPPLEMENTAL; PAGE 86 (PUBLISHED IN FEBRUARY 2020). CASE 2: THE PATIENT WAS A MALE IN HIS THIRTIES. HE HAD A HISTORY OF CEREBRAL PALSY AND HAD A TRACHEAL CANNULA IN PLACE. MASSIVE BLEEDING FROM THE TRACHEOSTOMY WAS OBSERVED, AND HE WAS TAKEN TO OUR HOSPITAL. CONTRAST-ENHANCED CT SUSPECTED TRACHEA-INNOMINATE ARTERY FISTULA. IT WAS CONSIDERED TO BE INOPERABLE DUE TO CONTRACTURE, SO THE PATIENT WAS REFERRED TO OUR DEPARTMENT. THE RIGHT SUBCLAVIAN ARTERY WAS COIL EMBOLIZED, AND A GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (8MM X 5CM) WAS IMPLANTED FROM THE INNOMINATE ARTERY TO THE RIGHT COMMON CAROTID ARTERY. HEMOSTASIS WAS OBTAINED. THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL, HOWEVER, ON POSTOPERATIVE DAY 8, THE PATIENT DIED OF RE-BLEEDING.

    Additional Manufacturer Narrative · 1

    DEVICE DISPOSITION UNKNOWN AT THIS TIME, THEREFORE, A DIRECT PRODUCT ANALYSIS IS UNAVAILABLE. THE INVESTIGATION IS ONGOING, MINIMAL INFORMATION IS AVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    THE FOLLOWING PUBLICATION WAS REVIEWED: INITIAL EXPERIENCE OF VIABAHN AT THE FACILITY CASE 2: THIS CASE WAS A MALE IN HIS THIRTIES. HE HAD A HISTORY OF CEREBRAL PALSY AND HAD A TRACHEAL CANNULA IN PLACE. MASSIVE BLEEDING FROM THE TRACHEOSTOMY WAS OBSERVED, AND HE WAS TAKEN TO OUR HOSPITAL. CONTRAST-ENHANCED CT SUSPECTED TRACHEA-INNOMINATE ARTERY FISTULA. IT WAS CONSIDERED TO BE INOPERABLE DUE TO CONTRACTURE, SO HE WAS REFERRED TO OUR DEPARTMENT. THE RIGHT SUBCLAVIAN ARTERY WAS COIL EMBOLIZED, AND A GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (8MM X 5CM) WAS IMPLANTED FROM THE INNOMINATE ARTERY TO THE RIGHT COMMON CAROTID ARTERY, AND HEMOSTASIS WAS OBTAINED. HE WAS TRANSFERRED TO ANOTHER HOSPITAL, HOWEVER, ON POSTOPERATIVE DAY 8, HE DIED OF RE-BLEEDING (CODED: 2203-A). THE VIABAHN DEVICE IS EFFECTIVE AS AN INITIAL TREATMENT FOR LIFE SAVING PURPOSES, HOWEVER, ADDITIONAL TREATMENT MAY NEED TO BE CONSIDERED DEPENDING ON THE TREATMENT SITE. PLEASE NOTE: CASE 1 IN THE ARTICLE SHOWS NO COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    585255 GORE VIABAHN ENDOPROSTHESIS - 3 NIP PFV W.L. GORE & ASSOCIATES

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Death