BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 1893416 · Received November 5, 2010

    Report

    Report Number
    2017233-2010-00492
    Event Type
    Injury
    Date Received
    November 5, 2010
    Date of Event
    October 19, 2010
    Report Date
    November 4, 2010
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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. THE GORE EXCLUDER AAA ENDOPROSTHESIS IS INTENDED TO EXCLUDE THE ANEURYSM FROM THE BLOOD CIRCULATION IN PTS DIAGNOSED WITH INFRARENAL ABDOMINAL AORTIC ANEURYSM (AAA) DISEASE AND WHO HAVE APPROPRIATE ANATOMY.

    Description of Event or Problem · 1

    ON AN UNK DATE, THIS PT WAS TREATED IN AN OPEN PROCEDURE FOR PULMONARY EMBOLI. THIS RESULTED IN A PSEUDO ANEURYSM IN THE ASCENDING AORTA. ON (B)(6) 2010, THE PT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT THE PSEUDO ANEURYSM IN THE ASCENDING AORTA WITH A AORTIC EXTENDER COMPONENT. AFTER DEPLOYMENT, THE AORTIC EXTENDER COMPONENT MIGRATED 15-20 MM TOWARDS THE AORTIC VALVE. THE PT WAS THEN CONVERTED TO OPEN REPAIR. THE PT EXPIRED BEFORE THE END OF THE PROCEDURE DUE TO PRE-EXISTING PULMONARY COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE EXCLUDER AAA ENDOPROSTHESIS MIH /S YSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES WLG325 06871932

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Hospitalization| R