BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 1972270 · Received January 20, 2011

    Report

    Report Number
    2953161-2011-00015
    Event Type
    Injury
    Date Received
    January 20, 2011
    Date of Event
    November 23, 2010
    Report Date
    January 19, 2011
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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.

    Description of Event or Problem · 1

    ON (B)(6), 2006, THIS PT UNDERWENT TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM WITH THREE GORE EXCLUDER AAA ENDOPROSTHESES. ON (B)(6), 2010, FOLLOW-UP IMAGING REPORTEDLY DEMONSTRATED AN UNSPECIFIED ENDOLEAK WITH ANEURYSM ENLARGEMENT OF 13 MM. ON (B)(6), 2011, AN INTERVENTION WAS PERFORMED TO TREAT THE ENDOLEAK. AS REPORTED, IT WAS THOUGHT THE ENDOLEAK WAS A DISTAL TYPE I ENDOLEAK, SO THE LEFT COMMON ILIAC ARTERY WAS EXTENDED WITH AN ADDITIONAL CONTRALATERAL LEG COMPONENT. IT WAS REPORTED THAT THE ADDITIONAL INTRA-OPERATIVE ANGIOGRAPHY AGAIN SHOWED AN ENDOLEAK. IT WAS REPORTEDLY DETERMINED THAT THE ENDOLEAK PREVIOUSLY THOUGHT AS A TYPE I WAS ACTUALLY A TYPE II ORIGINATING FROM A LUMBAR ARTERY AND FEEDING INTO THE ANEURYSM SAC. AS REPORTED, THE LUMBAR ARTERY WAS COIL EMBOLIZED, AND FINAL ANGIOGRAPHY DEMONSTRATED NO EVIDENCE OF ENDOLEAK. 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, INC. WLG325 04359601

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Hospitalization| R (B)(4)| ATENOLOL| ZOLOFT| (B)(4)| LIPITOR| HYDROCHLOROTHIAZIDE