BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 10404781 · Received August 13, 2020

    Report

    Report Number
    3007284313-2020-01035
    Event Type
    Injury
    Date Received
    August 13, 2020
    Date of Event
    April 26, 2018
    Report Date
    August 13, 2020
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    UDI-DI
    00733132622542
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS. ACCORDING TO THE GORE® EXCLUDER® AAA ENDOPROSTHESIS INSTRUCTIONS FOR USE (IFU), 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. ADDITIONALLY, PER IFU, ADVERSE EVENTS THAT MAY OCCUR AND / OR REQUIRE INTERVENTION INCLUDE, BUT ARE NOT LIMITED TO ENDOLEAK AND ANEURYSM ENLARGEMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED ON (B)(6) 2015, WITH A 60 MM ABDOMINAL AORTIC ANEURYSM THAT WAS TREATED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES. FOLLOW-UP IMAGING SHOWED THAT THE ANEURYSM SIZE APPEARED TO BE STABLE UNTIL ANEURYSM GROWTH WAS VISIBLE ON (B)(6) 2018 (68 MM). ON (B)(6) 2020, A TYPE II ENDOLEAK WAS IDENTIFIED ALONG WITH FURTHER ANEURYSM GROWTH TO 80MM. THE ENDOLEAK WAS SUCCESSFULLY TREATED WITH EMBOLIZATION ON (B)(6) 2020. THE PATIENT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    865957 GORE EXCLUDER AAA ENDOPROSTHESIS ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC. RLT281416 00733132622542

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Required Intervention