BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 1944433 · Received December 28, 2010

    Report

    Report Number
    2017233-2010-00575
    Event Type
    Injury
    Date Received
    December 28, 2010
    Date of Event
    December 14, 2010
    Report Date
    December 27, 2010
    Manufacturer
    W.L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE(S) WAS NOT POSSIBLE SINCE THE DEVICE LOT NUMBER(S) WERE UNAVAILABLE. ADD'L DEVICE RELATED TO THIS EVENT: PICC121200/ LOT# UNK. 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 TO PROVIDE A DESIGN ENHANCEMENT TO THE ORIGINAL GORE EXCLUDER BIFURCATED ENDOPROSTHESIS.

    Description of Event or Problem · 1

    ON AN UNKNOWN DATE IN 2004, THE PATIENT WAS IMPLANTED WITH GORE EXCLUDER BIFURCATED ENDOPROSTHESIS, FOR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM MEASURING 52MM. A COMPUTED TOMOGRAPHY (CT) SCAN PERFORMED ON (B)(6), 2010 DETERMINED THE PATIENT'S ANEURYSM MEASURES 65.61MM X 70.30MM. THE PATIENT IS DOING WELL AND IS BEING MONITORED BY THE PHYSICIAN. THERE IS NO EVIDENCE OF AN ENDOLEAK AND NO REINTERVENTION IS SCHEDULED.

    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, INC. WLG425

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other PCC121200, LOT # UNKNOWN