BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 3385800 · Received September 18, 2013

    Report

    Report Number
    2953161-2013-00125
    Event Type
    Injury
    Date Received
    September 18, 2013
    Date of Event
    January 6, 2012
    Report Date
    August 27, 2013
    Manufacturer
    W. L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MFG AND STERILIZATION RECORDS FOR THE DEVICES VERIFIED THAT THE LOTS MET ALL PRE-RELEASE SPECIFICATIONS.

    Description of Event or Problem · 1

    IN A REVIEW OF PUBLISHED LITERATURE, THESE FINDINGS WERE NOTED: MOTOKI NAKAI, MD, PHD, HIROTATSU SATO, MD, MORIO SATO, MD, PHD, ET AL. SUCCESSFUL ENDOVASCULAR TREATMENT OF ILIAC ARTERIOVESICAL FISTULA WITH SECONDARY STENT-GRAFT INFECTION. JOURNAL OF VASCULAR AND INTERVENTIONAL RADIOLOGY (VOL. 24, ISSUE 9:221-224). ON (B)(6) 2011, A (B)(6) WOMAN WAS ADMITTED TO THE HOSP BECAUSE OF MASSIVE GROSS HEMATURIA AND SHOCK. CONTRAST-ENHANCED CT REVEALED A PSEUDOANEURYSM OF THE LEFT EXTERNAL ILIAC ARTERY (EIA) AND MASSIVE HEMATOMA IN THE BLADDER WHEREBY ILIAC ARTERIOVESICAL FISTULA (IAVF) DEVELOPED. TWO GORE EXCLUDER AAA ENDOPROSTHESIS ILIAC EXTENDER COMPONENTS WERE IMPLANTED FROM THE COMMON ILIAC ARTERY TO THE EIA TO EXCLUDE THE PSEUDOANEURYSM. THE PROCEDURE RESULTED IN COMPLETE EXCLUSION OF THE PSEUDOANEURYSM AND SUCCESSFULLY CONTROLLED THE BLEEDING. RETROGRADE CYSTOGRAPHY WAS PERFORMED 10 DAYS AFTER THE PROCEDURE AND REVEALED LEAKAGE OF THE CONTRAST AGENT AROUND THE LEFT EIA THROUGH THE FISTULA FROM THE BLADDER. PROLONGED FEVER AND INFLAMMATION, WITH A HIGH C-REACTIVE PROTEIN LEVEL, WERE OBSERVED 30 DAYS AFTER THE PROCEDURE. CONTRAST-ENHANCED CT REVEALED PERI GRAFT AIR AROUND THE LEFT EIA. ESCHERICHIA COLI GREW IN BLOOD CULTURES. BASED ON THE CLINICAL SYMPTOMS, POSITIVE BLOOD CULTURE FINDINGS, AND CT FINDINGS, THE PT WAS DIAGNOSED WITH GRAFT-RELATED SEPSIS. THE PT RECEIVED LONG-TERM INTRAVENOUS ANTIBIOTIC THERAPY, BUT THIS TREATMENT DID NOT RESOLVE THE SEPSIS. ON (B)(6) 2011, RIGHT URINARY DIVERSION (IE, URETEROCUTANEOSTOMY) WAS PERFORMED BY AN UROLOGIST BECAUSE THE INFECTION WAS PROBABLY CAUSED BY URINE LEAKAGE FROM THE BLADDER FISTULA. ALTHOUGH THE C-REACTIVE PROTEIN LEVEL DECREASED TEMPORARILY, THE SEPSIS WAS NOT RESOLVED. ON (B)(6) 2012, THE PT UNDERWENT FEMOROFEMORAL BYPASS AND ENDOVASCULAR EMBOLIZATION OF THE STENT GRAFTS USING METALLIC COILS AND N-BUTYL CYANOACRYLATE. THE PT RECOVERED AND SHOWED NO SIGNS OF GRAFT INFECTION OR RECURRENT FISTULIZATION AT 14 MONTHS AFTER TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    469686 GORE EXCLUDER AAA ENDOPROSTHESIS MIH W. L. GORE & ASSOCIATES 9252530

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| R (B)(4)