BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 2392909 · Received December 22, 2011

    Report

    Report Number
    2017233-2011-00715
    Event Type
    Injury
    Date Received
    December 22, 2011
    Date of Event
    October 20, 2011
    Report Date
    November 30, 2011
    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

    RESULTS: THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS. PLEASE NOTE ADDITIONAL DEVICES IMPLANTED AND RELATED TO THIS EVENT: PXC121000/8931500.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE PATIENT WAS BEING TREATED WITH TWO GORE EXCLUDER AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THE PATIENT HAD A VERY TIGHT AORTA DUE TO EXCESSIVE CALCIUM AND THROMBUS AND WHEN THE PHYSICIAN WAS TRYING TO GAIN ACCESS TO THE CONTRALATERAL GATE, THE PATIENT'S AORTIC WALL WAS DISSECTED WITH THE GUIDEWIRE. THE DISSECTION WAS TREATED WITH THE IMPLANTED CONTRALATERAL LEG COMPONENT ONCE ACCESS WAS GAINED. IT WAS ALSO REPORTED THAT THE PATIENT'S ARTERY OF ADAMKIEWZ WAS ANATOMICALLY LOWER THAN NORMAL. THE PATIENT TOLERATED THE PROCEDURE AND NO COMPLICATIONS WERE REPORTED. ON (B)(6) 2011, THE PATIENT DEVELOPED PARAPARESIS. THE PHYSICIAN STATED THAT HE FELT THE PARAPARESIS WAS DUE TO THE PATIENT'S ARTERY OF ADAMKIEWZ BEING ANATOMICALLY LOWER. AT THIS TIME, THE PATIENT HAS SOME MOVEMENT IN HIS LOWER EXTREMITIES AND IS CURRENTLY IN PHYSICIAN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE EXCLUDER AAA ENDOPROSTHESIS MIH / SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES WLG425 8736135

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other THE PATIENT'S MEDICATIONS ARE UNAVAILABLE