BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 3597198 · Received January 10, 2014

    Report

    Report Number
    2017233-2014-00009
    Event Type
    Injury
    Date Received
    January 10, 2014
    Date of Event
    November 4, 2013
    Report Date
    December 13, 2013
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL EXCLUDER DEVICE INCLUDED IN THIS REPORT PXC121400/8896081. RESULTS PENDING COMPLETION OF MANUFACTURING AND STERILIZATION EVALUATIONS.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE PT WAS IMPLANTED WITH TWO GORE EXCLUDER AAA ENDOPROSTHESES. ON (B)(6) 2013, THE PT PRESENTED TO THE FACILITY COMPLAINING OF ABDOMINAL PAIN FOR THE PREVIOUS TWO WEEKS. ON THE SAME DAY, COMPUTED TOMOGRAPHY SCAN REPORTEDLY REVEALED AN INFECTED STENT GRAFT SYSTEM. THE ORIGIN OF THE INFECTION WAS NOT SPECIFIED. THE SCAN ALSO REPORTEDLY REVEALED PERIAORTIC EDEMA, AND TWO AREAS THAT MAY HAVE BEEN ABSCESSED. ON (B)(6) 2013, FLUID SURROUNDING THE GRAFTS WAS ASPIRATED FOR EVAL (RESULTS NOT AVAILABLE). ON (B)(6) 2013, THE PHYSICIAN EXPLANTED THE STENT GRAFT SYSTEM, AND SURGICALLY REPAIRED THE VASCULATURE. THE EXPLANTED GRAFTS WERE THOUGHT TO BE DISCARDED AT THE FACILITY. THE PT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20625 GORE EXCLUDER AAA ENDOPROSTHESIS MIH/SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 9250070

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| R PRO-AIR| ZYRTEC| NEXIUM| TRAMADOL| ASPIRIN| BYSTOLIC| CRESTOR| HYDROCHLOROTHIAZIDE