BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AORTIC EXCLUDER AAA ENDOPROSTHESIS (LOW PERM)

    MDR report key: 8208645 · Received January 2, 2019

    Report

    Report Number
    2953161-2019-00001
    Event Type
    Injury
    Date Received
    January 2, 2019
    Date of Event
    December 10, 2018
    Report Date
    December 10, 2018
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    UDI-DI
    00733132609918
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PER THE GORE® EXCLUDER AAA ENDOPROSTHESIS INSTRUCTIONS FOR USE (IFU), ADVERSE EVENTS THAT MAY OCCUR AND/OR REQUIRE INTERVENTION INCLUDE, BUT ARE NOT LIMITED TO ENDOPROSTHESIS COMPONENT MIGRATION, ENDOLEAK, AND ANEURYSM ENLARGEMENT. USERS ARE MADE AWARE OF THE RISKS ASSOCIATED WITH TYPE II ENDOLEAKS AND ARE INSTRUCTED TO CONSIDER THE RISKS AND BENEFITS DISCUSSED IN THE IFU FOR EACH PATIENT BEFORE USING THE DEVICES.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE PATIENT WAS IMPLANTED WITH TWO GORE® EXCLUDER AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. DURING THE PROCEDURE, A TYPE II ENDOLEAK WAS REPORTEDLY IDENTIFIED. THE PHYSICIAN DECIDED TO TAKE A WAIT-AND-WATCH APPROACH IN REGARD TO THE TYPE II ENDOLEAK AND COMPLETED THE PROCEDURE. ON AN UNKNOWN DATE, IT WAS REPORTED THAT THE ANEURYSM WAS ENLARGED DUE TO THE TYPE II ENDOLEAK ORIGINATING FROM THE VASA VASORUM. A DISTAL TYPE I ENDOLEAK SECONDARY TO PROXIMAL MIGRATION OF THE CONTRALATERAL LEG COMPONENT (B)(4) ON THE RIGHT SIDE WAS ALSO REPORTEDLY IDENTIFIED. ON (B)(6) 2018, THE PATIENT UNDERWENT A RE-INTERVENTION PROCEDURE WHEREBY THE RIGHT INTERNAL ILIAC ARTERY WAS COIL-EMBOLIZED, AND AN ADDITIONAL EXCLUDER® CONTRALATERAL LEG COMPONENT WAS IMPLANTED DISTALLY ON THE RIGHT SIDE TO TREAT THE DISTAL TYPE I ENDOLEAK. THE ENDOLEAK WAS RESOLVED. DURING THE SAME PROCEDURE, THE PHYSICIAN REPORTEDLY MADE AN ATTEMPT TO APPROACH THE VASA VASORUM THROUGH THE ANEURYSM TO TREAT THE TYPE II ENDOLEAK, BUT THE APPROACH WAS UNSUCCESSFUL. THE PHYSICIAN ABORTED TREATMENT OF THE TYPE II ENDOLEAK AND WILL CONTINUE TO MONITOR THE PATIENT. THE PATIENT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    463 AORTIC EXCLUDER AAA ENDOPROSTHESIS (LOW PERM) SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 10933616 00733132609918

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| R