BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 1882297 · Received October 21, 2010

    Report

    Report Number
    2953161-2010-00194
    Event Type
    Injury
    Date Received
    October 21, 2010
    Date of Event
    October 18, 2010
    Report Date
    October 21, 2010
    Manufacturer
    W. L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE PT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM WITH GORE EXCLUDER AAA ENDOPROSTHESES. THE PHYSICIAN PLACED THE TRUNK, THEN ATTEMPTED TO CANNULATE THE GATE FROM THE CONTRALATERAL SIDE. AFTER APPROX 20 MINUTES, HE CHANGED TO A SNARE METHOD FROM THE IPSILATERAL SIDE, AND AFTER ATTEMPTS WITH MULTIPLE CATHETERS, WAS ABLE TO CANNULATE. DURING THE FINAL ANGIOGRAM, THE PHYSICIAN SAW DECREASED BLOOD FLOW TO THE RIGHT RENAL ARTERY, SO A BARE METAL STENT WAS PLACED IN THE RENAL ARTERY. THE FINAL NEPHROGRAM SHOWED GOOD BLOOD FLOW TO THE ARTERY. THE PT IS FINE WITH NO OTHER COMPLICATIONS. THE PHYSICIAN ATTRIBUTED THE DECREASED RENAL BLOOD FLOW TO AN EMBOLIZATION DURING THE CANNULATION PORTION OF THE PROCEDURE. HE SAID THE SIMPSON CATHETER USED DURING THE ATTEMPTS TO SNARE FROM THE IPSILATERAL SIDE MAY HAVE DISLODGED CALCIUM OR THROMBUS IN THE AORTIC NECK.

    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 WLG325 8170710

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention