BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    MDR report key: 3915733 · Received July 7, 2014

    Report

    Report Number
    2017233-2014-00350
    Event Type
    Injury
    Date Received
    July 7, 2014
    Date of Event
    June 11, 2014
    Report Date
    July 16, 2014
    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

    NO RESULTS ARE AVAILABLE AS NO LOT NUMBERS WERE PROVIDED. THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED WITH THE PROVIDED INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(6).

    Description of Event or Problem · 1

    IN 2009 (EXACT DATE UNKNOWN), THE PATIENT UNDERWENT TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM WITH GORE® EXCLUDER® AAA ENDOPROSTHESES. ON AN UNKNOWN DATE, INFECTION OF THE ENDOGRAFT SYSTEM WAS IDENTIFIED. IT WAS REPORTED THE AORTA AND ENDOGRAFTS WERE SURROUNDED BY GREATER THAN 2 L OF STOOL-LIKE PUS, AND THE AORTA APPEARED TO BE NECROTIC AND ¿FALLING APART.¿ IT WAS REPORTED THE INFECTION WAS NOT RELATED TO THE EXCLUDER DEVICES. ON (B)(6) 2014, AN ADDITIONAL PROCEDURE WAS PERFORMED WHEREBY THE DEVICES WERE EXPLANTED, AND THE AORTA WAS REPAIRED SURGICALLY. THE PATIENT TOLERATED THE PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    393359 GORE® EXCLUDER® AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R