BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    MDR report key: 4276762 · Received November 25, 2014

    Report

    Report Number
    2017233-2014-00625
    Event Type
    Injury
    Date Received
    November 25, 2014
    Date of Event
    March 19, 2008
    Report Date
    December 3, 2014
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS.

    Additional Manufacturer Narrative · 1

    THE PROXIMAL TYPE I ENDOLEAK MIGHT BE DUE TO UNDER-SIZING OF THE STENT GRAFT AT THE PROXIMAL SIDE. THERE WAS A DISTAL TYPE I ENDOLEAK IN THE RIGHT COMMON ILIAC ARTERY, AND IT MIGHT HAVE BEEN CAUSED BY THE SHORT DISTAL LANDING ZONE. ON (B)(6) 2009, AN AORTIC EXTENDER COMPONENT (PXA260300/7005884) WAS IMPLANTED PROXIMALLY AND TWO ILIAC EXTENDER COMPONENTS (PXL161007/06814327, PXL161007/7002644) WERE IMPLANTED DISTALLY IN THE RIGHT LEG. THE DISTAL TYPE I ENDOLEAK WAS RESOLVED, BUT A TYPE II ENDOLEAK WAS REVEALED. A WAIT-AND-WATCH APPROACH HAD TAKEN FOR THE PATIENT¿S CONDITION AFTER THE REINTERVENTION. A FOLLOW-UP STUDY IN (B)(6) 2014 REVEALED ANEURYSM ENLARGEMENT PERSISTING. CAUSE OF THE CONTINUING ANEURYSM ENLARGEMENT COULD NOT BE IDENTIFIED.

    Description of Event or Problem · 1

    ON (B)(6) 2007, THE PATIENT UNDERWENT ENDOVASCULAR REPAIR OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESIS. THE PROCEDURE CONCLUDED SUCCESSFULLY AND NO ENDOLEAKS WERE SEEN. ON (B)(6) 2007, AT THE ONE-MONTH FOLLOW-UP, A PROXIMAL TYPE I ENDOLEAK AND A DISTAL TYPE I ENDOLEAK ON THE RIGHT SIDE WERE REVEALED. ANEURYSMAL DIAMETER MEASURED 90 MM X 86 MM. ON (B)(6) 2007, AT THE THREE-MONTH FOLLOW-UP, THE ENDOLEAKS WERE PERSISTING. THE ANEURYSMAL MEASURED 91 MM X 88 MM. ON (B)(6) 2008, AT THE SIX-MONTH FOLLOW-UP, THE ANEURYSM MEASURED 94 MM X 94 MM WITH THE TYPE I ENDOLEAKS STILL REMAINING. ON (B)(6) 2008, THE PATIENT WAS IMPLANTED WITH TWO AORTIC EXTENDER COMPONENTS PROXIMALLY AND A NON-GORE STENT GRAFT DISTALLY TO TREAT THE ENDOLEAKS. ON (B)(6) 2008, AT THE ONE-YEAR FOLLOW-UP, THE ENDOLEAKS WERE PERSISTING. THE ANEURYSM MEASURED 90 MM X 95 MM. A WAIT-AND-WATCH APPROACH WAS TAKEN TO THE ENDOLEAK AND THE ANEURYSM ENLARGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    763640 GORE® EXCLUDER® AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 05030218

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other (B)(6) 2007: PXC121200, PXC141000, PXC181000