BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE VIABAHN ENDOPROSTHESIS - 3

    MDR report key: 10146229 · Received June 11, 2020

    Report

    Report Number
    2017233-2020-00433
    Event Type
    Injury
    Date Received
    June 11, 2020
    Date of Event
    May 22, 2020
    Report Date
    July 30, 2020
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    PFV
    PMA / PMN Number
    P040037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. RESULTS CODE 2: 213: THE ENGINEERING EVALUATION STATED THE FOLLOWING: THE FOLLOWING OBSERVATIONS WERE MADE: THE ENDOPROSTHESIS WAS RETURNED IN FORMALIN SOLUTION. THE ENDOPROSTHESIS WAS FULLY EXPANDED AND HAD PIECES OF TISSUE ATTACHED. THE ENDOPROSTHESIS WAS UNREMARKABLE. ENGINEERING EVALUATION CONCLUSION IS INCONCLUSIVE AS IT RELATES TO THE EVENT DESCRIPTION. BASED ON THE DEVICE EXAMINATION PERFORMED, NO MANUFACTURING ANOMALIES WERE IDENTIFIED TO WHICH THE EVENT COULD BE DEFINITIVELY ATTRIBUTED. H.6. CONCLUSION CODE 1: UPDATED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL MANUFACTURING NARRATIVE: C1. NAME (#1) (B)(6). MANUFACTURER/COMPOUNDER: W. L. GORE & ASSOCIATES, INC. LOT #21908868. CBAS® HEPARIN SURFACE INCORPORATES CBAS-HEPARIN MANUFACTURED FROM HEPARIN SODIUM API, WHICH IS COVALENTLY BOUND TO THE DEVICE SURFACE AND IS ESSENTIALLY NON-ELUTING.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE VERIFIED THE LOT MET ALL PRE-RELEASE SPECIFICATIONS.

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2020 A PATIENT WAS UNDERGOING AN ENDOVASCULAR PROCEDURE TO SECURE THROMBUS AGAINST THE RIGHT EXTERNAL ILIAC VESSEL WALL WITH A GORE® VIABAHN® ENDOPROSTHESIS WITH PROPATEN BIOACTIVE SURFACE. FOLLOWING DEPLOYMENT OF THE DEVICE. A BALLOON WAS ADVANCED IN AN UP AND OVER THE AORTIC BIFURCATION APPROACH. HOWEVER THE BALLOON WOULD NOT TRACK THROUGH THE PROXIMAL PART OF THE DEVICE. DURING A SECOND ATTEMPT TO ADVANCE THE BALLOON, THE ENDOPROSTHESIS BEGAN TO MIGRATE DISTALLY TO THE COMMON FEMORAL/SUPERFICIAL FEMORAL ARTERY. THE ENDOPROSTHESIS WAS THEN EXPLANTED. AN ENDARTERECTOMY OF THE COMMON FEMORAL ARTERY WHICH WAS ORIGINALLY PLANNED FOR THE FOLLOWING DAY WAS ALSO PERFORMED. THE PATIENT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    606011 GORE VIABAHN ENDOPROSTHESIS - 3 NIP PFV W.L. GORE & ASSOCIATES 21908868

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| O| R