BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 2820552 · Received October 25, 2012

    Report

    Report Number
    2953161-2012-00192
    Event Type
    Injury
    Date Received
    October 25, 2012
    Date of Event
    September 7, 2012
    Report Date
    September 7, 2012
    Manufacturer
    W. L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE(S) VERIFIED THAT THE LOT(S) MET ALL PRE-RELEASE SPECIFICATIONS. THE GORE EXCLUDER AAA ENDOPROSTHESIS INSTRUCTIONS FOR USA (IFU) SPECIFIES "PATIENTS SHOULD BE COUNSELED AS TO THE POSSIBILITY OF SUBSEQUENT REINTERVENTIONS INCLUDING CATHETER-BASED AND OPEN SURGICAL CONVERSION." ADDITIONALLY, THE IFU STATES: ACCORDING TO THE GORE EXCLUDER AAA ENDOPROSTHESIS INSTRUCTIONS FOR USE, ADVERSE EVENTS THAT MAY OCCUR AND/OR REQUIRE INTERVENTION INCLUDE: ENDOLEAK.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM AND WAS IMPLANTED WITH GORE EXCLUDER AAA ENDOPROSTHESIS. THE PATIENT TOLERATED THE PROCEDURE WITH NO KNOWN COMPLICATIONS. ON (B)(6) 2012, COMPUTED TOMOGRAPHY SHOWED A SUSPECTED TYPE III ENDOLEAK THOUGHT TO BE CAUSED BY A HOLE IN THE MAIN BODY OF THE GRAFT. ON (B)(6) 2012, THE PATIENT UNDERWENT RE-INTERVENTION AND A GORE AORTIC EXTENDER COMPONENT WAS PLACED IN THE MAIN BODY OF THE DEVICE WHERE A HOLE HAD BEEN SUSPECTED. CONTRAST ANGIOGRAPHY AT THIS TIME DID NOT CONFIRM A HOLE IN THE DEVICE. THE PATIENT TOLERATED THE PROCEDURE AND THE ENDOLEAK APPEARED RESOLVED.

    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 8692476

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| O| R