BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 1882238 · Received October 21, 2010

    Report

    Report Number
    2017233-2010-00471
    Event Type
    Injury
    Date Received
    October 21, 2010
    Date of Event
    October 14, 2010
    Report Date
    October 20, 2010
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MFG RECORDS FOR THE DEVICE HAS BEEN CONDUCTED. A REVIEW OF THE MFG RECORDS FOR THE DEVICE(S) VERIFIED THAT THE LOT(S) MET ALL PRE-RELEASE SPECS. TYPE II ENDOLEAK. ADD'L DEVICES ALSO INVOLVED IN THIS EVENT INCLUDE: PXC201200/7625634, PXC201200/7405937, PXA230300/7512757. ACCORDING TO THE GORE EXCLUDER AAA ENDOPROSTHESIS INSTRUCTIONS FOR USE, TYPE II ENDOLEAKS ARE A KNOWN RISK FACTOR FOR ENDOVASCULAR TREATMENT OF ABDOMINAL AORTIC ANEURYSMS.

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE PT UNDERWENT TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM AND WAS IMPLANTED WITH GORE EXCLUDER AAA ENDOPROSTHESIS AND A CARDIOMEMS DEVICE. THE PT TOLERATED THE PROCEDURE. ON (B)(6) 2010, THE PT UNDERWENT AN ANGIOGRAM WHICH CONFIRMED A TYPE II ENDOLEAK ORIGINATING FROM THE RIGHT ILIOLUMBAR ARTERY. THERE WAS NO ANEURYSM ENLARGEMENT AND THERE IS NO REINTERVENTION PLANNED. THE PT IS ASYMPTOMATIC. THE PHYSICIAN IS GOING TO MONITOR THE PT.

    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 06854070

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other PT IS NOT ON ANY CONCOMITANT MEDICATIONS.