BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 925984 · Received October 10, 2007

    Report

    Report Number
    2953161-2007-00156
    Event Type
    Injury
    Date Received
    October 10, 2007
    Date of Event
    July 27, 2007
    Report Date
    October 10, 2007
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING PAPERWORK IS BEING CONDUCTED. ANEURYSM GROWTH IN THE ABSENCE OF ENDOLEAKS HAS BEEN DEFINED AS ENDOTENSION IN THE LITERATURE. ONE HYPOTHESIS FOR THE SOURCE OF ENDOTENSION IS THE TRANSMURAL MOVEMENT OF SEROUS FLUID ACROSS THE MATERIAL USED TO FABRICATE DEVICES USED TO TREAT THE AORTIC ABDOMINAL ANEURYSM. EVIDENCE SUPPORTING THIS HYPOTHESIS HAS BEEN GATHERED DURING SURGICAL CONVERSIONS, TRANSLUMBAR PUNCTURES OF THE AORTIC ABDOMINAL ANEURYSM AND LAPAROSCOPIC EXPLORATION OF THE AORTIC ABDOMINAL ANEURYSM SAC CONTENTS. DUE TO THESE OBSERVATIONS GORE ELECTED TO PROVIDE A DESIGN ENHANCEMENT TO THE ORIGINAL GORE EXCLUDER BIFURCATED ENDOPROSTHESIS. THE DEVICE USED IN THIS PARTICULAR CASE WAS THE ORIGINAL GORE EXCLUDER BIFURCATED ENDOPROSTHESIS. PLEASE SEE ATTACHED LIST OF ADDITIONAL DEVICES IMPLANTED IN THIS PATIENT: PC 14-12-00 / 9925401-17, PXA230300 / 05046268, PXC141400 / 04908337, PXC141200 / 05124411.

    Description of Event or Problem · 1

    IN 2000, THIS PATIENT RECEIVED GORE EXCLUDER BIFURCATED ENDOPROSTHESES. A TYPE II ENDOLEAK FROM THE IMA WAS NOTED DURING THE ONE MONTH FOLLOW-UP THE FOLLOWING MONTH. A SECOND TYPE II ORIGINATING FROM A LUMBAR ARTERY WAS NOTED ON APPROX FIVE MONTHS LATER. A REINTERVENTION TOOK PLACE ON THE FOLLOWING MONTH, TO COIL EMBOLIZE THE LUMBAR ARTERY; HOWEVER, THE TYPE II ENDOLEAKS PERSISTED. ONE YEAR LATER, IT WAS NOTED THAT THE ENDOLEAKS HAD RESOLVED, AND THE ANEURYSM SAC HAD DECREASED. FROM 2002 TO 2004, THE ANEURYSM INCREASED IN DIAMETER WITHOUT EVIDENCE OF AN ENDOLEAK. A SECOND REINTERVENTION TOOK PLACE IN 2007 TO RELINE THE ORIGINAL DEVICES WITH GORE EXCLUDER AAA ENDOPROSTHESES. THE PROCEDURE WAS SUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE EXCLUDER AAA ENDOPROSTHESIS ENDOVASCULAR GRAFT SYSTEM MIH W. L. GORE & ASSOCIATES, INC. WLG325 9834803-06

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention