BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    MDR report key: 7240352 · Received February 5, 2018

    Report

    Report Number
    2017233-2018-00075
    Event Type
    Injury
    Date Received
    February 5, 2018
    Date of Event
    August 28, 2013
    Report Date
    January 10, 2018
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UDI FOR GORE® EXCLUDER® TRUNK-IPSILATERAL LEG COMPONENT RMT231216/9955681: (B)(4). THE REVIEW OF THE MANUFACTURING RECORDS VERIFIED THAT THE LOTS INVOLVED IN THIS EVENT MET ALL PRE-RELEASE SPECIFICATIONS. ACCORDING TO THE GORE® EXCLUDER® AAA ENDOPROSTHESIS INSTRUCTIONS FOR USE (IFU), COMPLICATIONS ASSOCIATED WITH THE USE OF THE GORE® EXCLUDER® AAA ENDOPROSTHESIS MAY INCLUDE BUT ARE NOT LIMITED TO: ENDOLEAKS. (B)(4).

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2012, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ANEURYSM OF THE RIGHT COMMON ILIAC ARTERY MEASURING 48.3 MM AND WAS TREATED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES. ON (B)(6) 2013, FOLLOW-UP COMPUTED TOMOGRAPHY IMAGING REVEALED AN ANEURYSM DIAMETER OF 42 MM. BETWEEN (B)(6) 2013, AND (B)(6) 2015, VARIOUS FOLLOW-UP ULTRASOUND EXAMINATIONS IDENTIFIED ANEURYSM DIAMETERS RANGING BETWEEN 46 AND 55 MM, RESPECTIVELY. ON (B)(6) 2015, THE PATIENT WAS ADMITTED FOR TREATMENT OF A RIGHT COMMON ILIAC ARTERY TYPE II ENDOLEAK AND THE ENDOLEAK WAS SELECTIVELY COIL EMBOLIZED VIA A BRANCH OF THE MEDIAL CIRCUMFLEX ILIAC ARTERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86323 GORE® EXCLUDER® AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 9955681

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention