BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 10984295 · Received December 10, 2020

    Report

    Report Number
    2017233-2020-01517
    Event Type
    Injury
    Date Received
    December 10, 2020
    Date of Event
    December 9, 2020
    Report Date
    September 21, 2021
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    UDI-DI
    00733132610006
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    G3/G4: DATE AWARE OF 12/09/2020 ADDED, REGULATORY CLEARANCE P020004 ADDED.

    Additional Manufacturer Narrative · 0

    H.6. RESULTS CODE 1: 213: A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE VERIFIED THE LOT MET ALL PRE-RELEASE SPECIFICATIONS.

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE GORE® EXCLUDER® AAA ENDOPROSTHESIS INSTRUCTIONS FOR USE (IFU), ADVERSE EVENTS THAT MAY OCCUR AND/OR REQUIRE INTERVENTION INCLUDE, BUT ARE NOT LIMITED TO COMPONENT MIGRATION AND ENDOLEAK.

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2011, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT USING GORE® EXCLUDER® AAA ENDOPROSTHESIS FOR AN ABDOMINAL AORTIC ANEURYSM. ON AN UNKNOWN DATE, A DISTAL TYPE I ENDOLEAK DUE TO THE MIGRATION OF LEFT LIMB WAS OBSERVED. ON (B)(6) 2020, THE PATIENT UNDERWENT A REINTERVENTION. THE LEFT INTERNAL ILIAC ARTERY WAS COIL EMBOLIZED, AND AN ADDITIONAL STENT GRAFT WAS DEPLOYED TO EXTEND THE DEVICE TO THE RIGHT EXTERNAL ILIAC ARTERY. THE PHYSICIAN SUGGESTED THAT IT WAS DUE TO SLIGHTLY POOR VASCULAR CONDITION AND SHORT NECK FROM THE INITIAL PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1453705 GORE EXCLUDER AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC. PXC181000 00733132610006

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Hospitalization| O| R