BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 2132218 · Received June 14, 2011

    Report

    Report Number
    2017233-2011-00279
    Event Type
    Injury
    Date Received
    June 14, 2011
    Date of Event
    April 7, 2011
    Report Date
    June 13, 2011
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MFG PAPERWORK HAS BEEN CONDUCTED. THE REVIEW OF THE MFG PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS. AS STATED IN THE GORE EXCLUDER AAA ENDOPROSTHESIS INSTRUCTIONS FOR USE, COMPLICATIONS THAT MAY OCCUR AND/OR REQUIRE INTERVENTION INCLUDE, BUT ARE NOT LIMITED TO, EMBOLIZATION (MICRO AND MACRO) WITH TRANSIENT OR PERMANENT ISCHEMIA, AND RENAL FAILURE. (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE PT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM USING GORE EXCLUDER AAA ENDOPROSTHESIS FEATURING THE C3 DELIVERY SYSTEM. NO COMPLICATIONS WERE REPORTED. IT WAS NOTED THAT THE GORE GRAFTS DID NOT COVER THE LEFT RENAL ARTERY. THE PT TOLERATED THE PROCEDURE WELL. POSTOPERATIVELY (WITHIN 30 DAYS), THE PT SUFFERED LEFT KIDNEY INFARCTION. PT WAS REPORTED TO BE STABLE. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED.

    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 8778005

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| O