BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 2132201 · Received June 13, 2011

    Report

    Report Number
    2953161-2011-00138
    Event Type
    Injury
    Date Received
    June 13, 2011
    Date of Event
    May 18, 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
    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. ANEURYSM GROWTH IN THE ABSENCE OF ENDOLEAK HAS BEEN DEFINED AS ENDOTENSION. ONE HYPOTHESIS FOR THE SOURCE OF ENDOTENSION IS THE TRANSMURAL MOVEMENT OF SERIOUS FLUID ACROSS THE MATERIAL USED TO FABRICATE DEVICES USED TO TREAT THE AORTIC ABDOMINAL ANEURYSM. IN RESPONSE TO THIS ISSUE, GORE ELECTED TO PROVIDE A DESIGN ENHANCEMENT TO THE ORIGINAL GORE EXCLUDER BIFURCATED ENDOPROSTHESIS.

    Description of Event or Problem · 1

    ON (B)(6) 2003, THIS PT WAS IMPLANTED WITH GORE EXCLUDER BIFURCATED ENDOPROSTHESIS FOR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. APPROX TWO WEEKS BEFORE REINTERVENTION, CT SCAN REVEALED ANEURYSM GROWTH WITH NO SIGN OF ENDOLEAK. ON (B)(6) 2011, THIS PT HAD A REINTERVENTION TO TREAT ANEURYSM GROWTH WITH NO SIGN OF ENDOLEAK. ADDITIONAL GORE EXCLUDER AAA ENDOPROSTHESES WERE IMPLANTED TO RELINE THE GRAFT. 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 WLG425 032090601

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R PCL161407/(B)(4)| PCA280300/(B)(4)| PCC201400/(B)(4)| PCC201200/(B)(4)| PCA280300/(B)(4)| PCL161407/(B)(4)