BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 1881569 · Received October 20, 2010

    Report

    Report Number
    2017233-2010-00467
    Event Type
    Malfunction
    Date Received
    October 20, 2010
    Date of Event
    May 23, 2005
    Report Date
    October 20, 2010
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING PAPERWORK HAS BEEN CONDUCTED. A REVIEW OF THE STERILIZATION PAPERWORK HAS BEEN CONDUCTED. THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS. THE REVIEW OF THE STERILIZATION PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS.

    Description of Event or Problem · 1

    ON (B)(6) 2005, THE PATIENT WAS IMPLANTED WITH TWO GORE EXCLUDER AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. AFTER THE IMPLANT, THE PATIENT EXPERIENCED MULTIPLE HOSPITALIZATIONS SECONDARY TO FEVER, CHILLS, LOWER BACK AND ABDOMINAL PAIN WITH NO KNOWN CAUSE. ON (B)(6) 2005, THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH HIGH FEVER, CHILLS, AND ABDOMINAL PAIN. IT WAS ASSESSED BY THE PHYSICIANS THAT THE PATIENT HAD AN INFECTED STENT GRAFT. ON (B)(6) 2005, THE DEVICES WERE EXPLANTED. NO PATHOLOGY OF THE DEVICES WAS AVAILABLE. THE PATIENT TOLERATED THE PROCEDURE.

    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 WLG325 03493216

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R (B)(4)