BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 3143083 · Received May 29, 2013

    Report

    Report Number
    2953161-2013-00080
    Event Type
    Injury
    Date Received
    May 29, 2013
    Date of Event
    May 6, 2013
    Report Date
    May 6, 2013
    Manufacturer
    W. L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL EXCLUDER COMPONENTS INCLUDED IN THIS REPORT: PCC161000/03087461, PCA280300/031480901. RESULTS: A REVIEW OF MANUFACTURING RECORDS FOR THE DEVICES VERIFIED THAT THE LOTS MET ALL PRE-RELEASE SPECIFICATIONS. CONCLUSIONS: ANEURYSM GROWTH IN THE ABSENCE OF ENDOLEAK HAS BEEN DEFINED AS ENDOTENSION. 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. IN RESPONSE TO THIS ISSUE, GORE ELECTED IN 2004 TO PROVIDE A DESIGN ENHANCEMENT TO THE ORIGINAL GORE EXCLUDER BIFURCATED ENDOPROSTHESIS.

    Description of Event or Problem · 1

    ON (B)(6) 2004, THE PATIENT WAS IMPLANTED WITH THREE ORIGINAL GORE EXCLUDER AAA ENDOPROSTHESIS TO TREAT AN ABDOMINAL AORTIC ANEURYSM. ON AN UNKNOWN DATE IN (B)(6) 2011, A FOLLOW-UP ANGIOGRAM CONFIRMED A DISTAL TYPE I ENDOLEAK IN THE RIGHT COMMON ILIAC ARTERY. ON (B)(6) 2011, THE PATIENT WAS IMPLANTED WITH A GORE EXCLUDER AAA ENDOPROSTHESIS CONTRALATERAL LEG COMPONENT TO TREAT THE TYPE I ENDOLEAK. THIS TYPE I WAS RESOLVED, AND THE PATIENT TOLERATED THIS PROCEDURE. ON AN UNKNOWN DATE IN THE FIRST WEEK OF (B)(6) 2013, A FOLLOW-UP DOPPLER ULTRASOUND DETECTED BLOOD FLOW INTO THE ANEURISMAL SAC FROM AN INDETERMINATE ORIGIN. THE PHYSICIAN SUSPECTED ENDOTENSION HAD CONTRIBUTED TO ANEURISMAL GROWTH FROM A REPORTED 5.7 TO 6.3 CM IN DIAMETER. ON (B)(6) 2013, THE PHYSICIAN RELINED THE PATIENT'S STENT GRAFT SYSTEM WITH LOW-PERMEABILITY GORE EXCLUDER AAA ENDOPROSTHESIS. THE PROCEDURE WAS COMPLETED WITH NO EVIDENCE OF ENDOLEAK OR ENDOTENSION. THE PATIENT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235131 GORE EXCLUDER AAA ENDOPROSTHESIS MIH / SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES 033520311

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Hospitalization| R NEXIUM| ASPIRIN| LOSARTAN| LEVOTHYROXINE