BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AORTIC EXCLUDER AAA ENDOPROSTHESIS (C3)

    MDR report key: 10194069 · Received June 25, 2020

    Report

    Report Number
    3007284313-2020-00159
    Event Type
    Injury
    Date Received
    June 25, 2020
    Date of Event
    February 19, 2018
    Report Date
    May 28, 2020
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    UDI-DI
    00733132610761
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 ON (B)(6) 2011, THE PATIENT PRESENTED WITH A 55 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 (B)(6) 2017 (52 MM). ANEURYSM GROWTH TO 60 MM WAS VISIBLE ON (B)(6) 2018. CONTINUOUS ANEURYSM GROWTH TO 65 MM WAS IDENTIFIED ON (B)(6) 2019. ON (B)(6) 2019, A TYPE II ENDOLEAK OF UNSPECIFIED ORIGIN WAS IDENTIFIED AND SUCCESSFULLY TREATED WITH EMBOLIZATION ON (B)(6) 2019. THE PATIENT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660672 AORTIC EXCLUDER AAA ENDOPROSTHESIS (C3) SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES RMT311417 9016838 00733132610761

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention