BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE VIABAHN ENDOPROSTHESIS - 3

    MDR report key: 9582835 · Received January 13, 2020

    Report

    Report Number
    2017233-2020-00027
    Event Type
    Injury
    Date Received
    January 13, 2020
    Date of Event
    September 7, 2017
    Report Date
    March 2, 2020
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    PFV
    PMA / PMN Number
    P040037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT.

    Additional Manufacturer Narrative · 1

    REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE PERFORMED AS NO LOT NUMBER INFORMATION WAS PROVIDED. THE DEVICE WAS NOT RETURNED. CONSEQUENTLY, DIRECT PRODUCT ANALYSIS WAS NOT POSSIBLE. ADDITIONAL INFORMATION ABOUT THIS EVENT COULD NOT BE OBTAINED. AS A RESULT, NO CONCLUSION CAN BE DRAWN. ALL INFORMATION HAS BEEN PLACED ON FILE FOR USE IN TRACKING AND TRENDING. IT IS UNCLEAR IF THE IMPLANTED DEVICE WAS GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (REF MEDWATCH #2017233-2020-00028) OR GORE® VIABAHN® ENDOPROSTHESIS.

    Description of Event or Problem · 1

    PUBLISHED ABSTRACT "TWO-YEAR EVALUATION OF FENESTRATED AND PARALLEL BRANCH ENDOGRAFTS FOR THE TREATMENT OF JUXTARENAL, SUPRARENAL,AND THORACOABDOMINAL ANEURYSMS AT A SINGLE INSTITUTION" (MOHSEN BANNAZADEH, M.D., WILLIAM E. BECKERMAN, M.D., ADAM H. KORAYEM, M.D., AND JAMES F. MCKINSEY, M.D., NEW YORK, NY; COPYRIGHT 2019 PUBLISHED BY ELSEVIER INC. ON BEHALF OF THE SOCIETY FOR VASCULAR SURGERY; HTTPS://DOI.ORG/10.1016/J.JVS.2019.03.058) WAS REVIEWED. THE ABSTRACT DISCUSSES THE MORTALITY, GRAFT PATENCY, RENAL FUNCTION, COMPLICATION, AND REINTERVENTION RATES FOR FENESTRATED AND PARALLEL ENDOGRAFTS IN COMPLEX AORTIC ANEURYSMS REPAIRS FROM AUGUST 2014 TO MARCH 2017 IN A SINGLE CENTER. THE ABSTRACT REPORTED IN THE REINTERVENTION, BRANCH REINTERVENTION, AND ENDOLEAKS SECTION ONE RENAL STENT GRAFT KINKED. IT IS UNCLEAR IF THE IMPLANTED DEVICE WAS GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS OR GORE® VIABAHN® ENDOPROSTHESIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46461 GORE VIABAHN ENDOPROSTHESIS - 3 NIP PFV W.L. GORE & ASSOCIATES

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other