BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 2879105 · Received December 12, 2012

    Report

    Report Number
    2017233-2012-00826
    Event Type
    Injury
    Date Received
    December 12, 2012
    Date of Event
    January 1, 2012
    Report Date
    December 6, 2012
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INFO WAS REQUESTED. A REVIEW OF THE MFG RECORDS FOR THE DEVICE IS BEING CONDUCTED. THE DATE OF THE IMPLANT PROCEDURE IS UNK. THE DATE OF EVENT IS UNK.

    Description of Event or Problem · 1

    ON AN UNK DATE IN 2007, THE PT WAS IMPLANTED WITH A GORE EXCLUDER AAA ENDOPROSTHESIS TO TREAT AN ABDOMINAL AORTIC ANEURYSM. ON AN UNK DATE, F/U IMAGING REVEALED A TYPE II ENDOLEAK FROM LUMBAR ARTERIES, HOWEVER, THE ANEURYSM DIAMETER DID NOT GROW. DURING A COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) IN 2012, IT WAS NOTED THAT THE ANEURYSM DIAMETER HAD GROWN. FLOW FROM LUMBAR ARTERIES WAS NOTED TO BE REDUCED. THE PHYSICIAN WAS CONCERNED ABOUT A POSSIBLE TYPE II ENDOLEAK NEAR THE RIGHT ILIAC LIMB OR A POSSIBLE DISTAL TYPE I ENDOLEAK FROM THE LCI. IT WAS REPORTED THAT THE EXCLUDER LIMB WAS EXTENDING APPROX 1 CM INTO THE LCI AND THE DIAMETER OF THE LCI APPEARED TO HAVE EXPANDED. THE PHYSICIAN IS PLANNING A CTA TO DETERMINE THE SOURCE OF THE ENDOLEAK AND ASSESS TREATMENT OPTIONS. THERE IS NO SEQUELA REGARDING THIS PT. FURTHER INFO WAS REQUESTED.

    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

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Hospitalization| O