BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AORTIC EXCLUDER AAA ENDOPROSTHESIS (LOW PROFILE)

    MDR report key: 8443032 · Received March 22, 2019

    Report

    Report Number
    2953161-2019-00027
    Event Type
    Injury
    Date Received
    March 22, 2019
    Date of Event
    February 17, 2019
    Report Date
    May 6, 2019
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    UDI-DI
    00733132618576
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    PLEASE NOTE: THIS MEDWATCH REPORT IS ASSOCIATED WITH MFR# 2953161-2019-00028. H6: CODE 22 - 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: ENDOLEAK.

    Description of Event or Problem · 0

    ON FEBRUARY 17, 2019, FOLLOW-UP COMPUTED TOMOGRAPHY IMAGING IDENTIFIED A TYPE III ENDOLEAK INVOLVING A DISCONNECTION BETWEEN THE GORE® EXCLUDER® CONTRALATERAL LEG COMPONENT PLC231000 AND THE GORE® EXCLUDER® ILIAC BRANCH COMPONENT CEB231410.

    Additional Manufacturer Narrative · 1

    PLEASE NOTE: THIS MEDWATCH REPORT IS ASSOCIATED WITH MFR# 2953161-2019-00028. ADDITIONAL DEVICE INVOLVED IN THIS EVENT: GORE® EXCLUDER® ILIAC BRANCH COMPONENT (B)(4)/16240389 WITH UDI (B)(4).

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2017, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM AND AN ANEURYSM OF THE COMMON ILIAC ARTERY. THE PATIENT WAS THEREFORE IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES AS WELL AS GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESES. REPORTEDLY, THE PROCEDURE WENT WELL. ON AN UNKNOWN DATE, FOLLOW-UP COMPUTED TOMOGRAPHY IMAGING IDENTIFIED A TYPE III ENDOLEAK INVOLVING A DISCONNECTION BETWEEN THE GORE® EXCLUDER® CONTRALATERAL LEG COMPONENT PLC231000 AND THE GORE® EXCLUDER® ILIAC BRANCH COMPONENT (B)(4). THERE WERE NO SPECIFIC ADVERSE ANATOMICAL ISSUES AND A CAUSE FOR THE DISCONNECTION WAS REPORTEDLY UNKNOWN. ON (B)(6) 2019, THE DISCONNECTION WAS RELINED WITH AN ADDITIONAL GORE® EXCLUDER® CONTRALATERAL LEG COMPONENT AND NO ENDOLEAK WAS OBSERVED DURING FINAL IMAGING. THE PATIENT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    239232 AORTIC EXCLUDER AAA ENDOPROSTHESIS (LOW PROFILE) SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 15768138 00733132618576

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R