BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 11901309 · Received May 28, 2021

    Report

    Report Number
    2017233-2021-02034
    Event Type
    Injury
    Date Received
    May 28, 2021
    Date of Event
    April 30, 2021
    Report Date
    October 19, 2021
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION FINDINGS, CONCLUSION CODE.

    Additional Manufacturer Narrative · 0

    G1. MANUFACTURING SITE NAME AND ADDRESS: W.L. GORE. MEDICAL PHOENIX 2. 32470 N NORTH VALLEY PKWY. PHOENIX, AZ 85085.

    Additional Manufacturer Narrative · 0

    UPDATED G1 MANUFACTURING LOCATION TO WL GORE SILICONE VALLEY.

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE GORE¿ EXCLUDER¿ AAA ENDOPROSTHESIS FEATURING C3 DEPLOYMENT SYSTEM INSTRUCTIONS FOR USE, POTENTIAL ADVERSE EVENTS THAT MAY OCCUR AND/OR REQUIRE INTERVENTION INCLUDE, BUT ARE NOT LIMITED TO, ENDOLEAK. 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. SPECIFICALLY, THE IFU WARNS THAT ADVERSE EVENTS THAT MAY OCCUR AND / OR REQUIRE INTERVENTION INCLUDE BUT ARE NOT LIMITED TO ENDOLEAK.

    Description of Event or Problem · 1

    ON (B)(6) 2019, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING GORE¿ EXCLUDER¿ AAA ENDOPROSTHESIS FEATURING C3 DEPLOYMENT SYSTEM. ON (B)(6) 2021, FOLLOW UP CT IMAGING REVEALED ANEURYSM ENLARGEMENT, AND A TYPE III ENDOLEAK (COMPONENT DISCONNECTION) WAS SUSPECTED. A REINTERVENTION TOOK PLACE, AND THE INTRA-OPERATIVE ANGIOGRAPHY IMAGING CONFIRMED A TYPE III ENDOLEAK (COMPONENT DISCONNECTION), AND A TYPE II ENDOLEAK FROM THE LUMBAR ARTERY VIA THE LEFT INTERNAL ILIAC ARTERY. AN ADDITIONAL STENT GRAFT WAS PLACED AT THE COMPONENT OVERLAP JUNCTION, AND COIL EMBOLIZATION OF THE LUMBAR ARTERY WAS PERFORMED. THE ENDOLEAKS WERE RESOLVED. THE PATIENT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    797311 GORE EXCLUDER AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention PLC181000J/18853479