BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 2833116 · Received November 6, 2012

    Report

    Report Number
    2017233-2012-00750
    Event Type
    Injury
    Date Received
    November 6, 2012
    Date of Event
    October 12, 2012
    Report Date
    October 12, 2012
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULT - THE REVIEW OF THE MFG PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECS.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE PT WAS IMPLANTED WITH TWO GORE EXCLUDER AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. ON (B)(6) 2012, A COMPUTED TOMOGRAPHY ANGIOGRAM REVEALED A PROXIMAL TYPE I ENDOLEAK. ANEURYSM GROWTH WAS NOT NOTED. ON (B)(6) 2012, THE PT WAS IMPLANTED WITH A GORE EXCLUDER AAA ENDOPROSTHESIS AORTIC EXTENDER COMPONENT TO TREAT THE ENDOLEAK. THE ENDOLEAK WAS RESOLVED AND THE PT TOLERATED THE PROCEDURE.

    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 9524984

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| R MULTI-VITAMIN| CADVET| LISINOPRIL| NASACORD| METFORMIN| ASPIRIN| PROAIR| GREEN TEA EXTRACT| FISH OIL