BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 1020579 · Received March 28, 2008

    Report

    Report Number
    2953161-2008-00057
    Event Type
    Injury
    Date Received
    March 28, 2008
    Date of Event
    October 11, 2007
    Report Date
    March 27, 2008
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MFG PAPERWORK HAS BEEN CONDUCTED. THE REVIEW OF THE MFG PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS. PLEASE NOTE, THIS MEDWATCH WAS ORIGINALLY REPORTED UNDER MEDWATCH #2017233-2007-00363. PLEASE NOTE ATTACHED LIST OF ADD'L DEVICES IMPLANTED AND INVOLVED IN THIS EVENT; AORTIC EXTENDER COMPONENTS (PXA230300/04407114, PXA2320300/04407113 AND PXA260300/04094241).

    Description of Event or Problem · 1

    THIS PT WAS ORIGINALLY IMPLANTED APPROX 1 YR AGO WITH A GORE EXCLUDER AAA ENDOPROSTHESIS TRUNK-IPSILATERAL LEG COMPONENT, CONTRALATERAL LEG COMPONENT AND 3 AORTIC EXTENDER COMPONENTS. IN 2007, THIS PT PRESENTED WITH ABDOMINAL PAIN TO THE ER. A COMPUTED TOMOGRAPHY WAS TAKEN REVEALING A TYPE III ENDOLEAK SECONDARY TO A DISCONNECT BETWEEN TWO AORTIC EXTENDER COMPONENTS WHICH WERE LOCATED WITHIN THE LEFT COMMON ILIAC. AS REPORTED, THIS DISCONNECT CAUSED THE CONTRALATERAL LEG COMPONENT AND ONE OF THE AORTIC EXTENDER COMPONENTS TO RETRACT INTO THE ANEURYSM SAC, LEAVING THE OTHER AORTIC EXTENDER COMPONENT IN THE LEFT COMMON ILIAC. THE COMPUTED TOMOGRAPHY ALSO REVEALED A STABLE ANEURYSM AND A GOOD SEAL ON THE RIGHT SIDE. A REINTERVENTION WAS IMMEDIATELY PERFORMED BY CANNULATING THE CONTRALATERAL LEG COMPONENT AND AORTIC EXTENDER COMPONENT THAT WERE IN THE SAC AND PUTTING ANOTHER CONTRALATERAL LEG COMPONENT, AND AORTIC EXTENDER COMPONENT IN PLACE TO SECURE THE DEVICES TOGETHER. THE PT IS REPORTEDLY DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE EXCLUDER AAA ENDOPROSTHESIS ENDOVASCULAR GRAFT SYSTEM MIH W. L. GORE & ASSOCIATES, INC. WLG325 042580216

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention