BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA PROSTHESIS

    MDR report key: 2470958 · Received February 22, 2012

    Report

    Report Number
    2953161-2012-00038
    Event Type
    Injury
    Date Received
    February 22, 2012
    Date of Event
    October 20, 2011
    Report Date
    February 9, 2012
    Manufacturer
    W. L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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: PXC181200/6984348.

    Description of Event or Problem · 1

    ON (B)(6) 2009, THE PT WAS IMPLANTED WITH TWO GORE EXCLUDER AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM AND A RIGHT COMMON ILIAC ARTERY ANEURYSM. ON (B)(6) 2011, A COMPUTED TOMOGRAPHY REVEALED DISEASE PROGRESSION AND ANEURYSM GROWTH FROM THE RIGHT COMMON ILIAC ARTERY ANEURYSM. ON (B)(6) 2011, THE PT'S RIGHT INTERNAL ILIAC ARTERY WAS COIL EMBOLIZED AND THE PT WAS IMPLANTED WITH TWO GORE EXCLUDER AAA ENDOPROSTHESES TO TREAT THE GROWING ANEURYSM. THE PT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE EXCLUDER AAA PROSTHESIS MIH/SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES WLG425 06668400

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| R NIASON| ZOCOR| METFORMIN| METEPROLOL| HCTZ| CARDURA| ASPIRIN