BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 2801469 · Received October 11, 2012

    Report

    Report Number
    2017233-2012-00710
    Event Type
    Injury
    Date Received
    October 11, 2012
    Date of Event
    July 14, 2008
    Report Date
    September 17, 2012
    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

    LANE ET AL. (2009). AORTODUODENAL FISTULA AFTER ENDOVASCULAR ANEURYSM REPAIR PRESENTING WITH ANEURYSM SAC ABSCESS. JOURNAL OF VASCULAR SURGERY, 50, 919-920.

    Description of Event or Problem · 1

    ON AN UNK DATE, SOMETIME AROUND OR PRIOR TO (B)(6) 2008, THE PT UNDERWENT ENDOVASCULAR REPAIR OF A 10-CM INFRARENAL ABDOMINAL AORTIC ANEURYSM WITH GORE EXCLUDER AAA ENDOPROSTHESIS. THERE WAS NO PREOPERATIVE EVIDENCE OF AN INFLAMMATORY OR MYCOTIC ANEURYSM. A CT PERFORMED 3 MONTHS POSTOPERATIVELY SHOWED MILD PERIGRAFT STANDING WITH NO EVIDENCE OF ENDOLEAK. SIX MONTHS POST-OPERATIVELY, THE PT PRESENTED WITH FEVERS, CHILLS, LETHARGY, AND DIARRHEA. A CT SHOWED MASSIVE AMOUNTS OF AIR AROUND THE ENDOGRAFT AND WITHIN THE ANEURYSM SAC. OPERATIVE EXPLORATION REVEALED A PARAPROSTHETIC AORTODUODENAL FISTULA (ADF) WITH GROSS SUPPURATION WITHIN THE ANEURYSM SAC, WITHOUT DISTRIBUTION OF THE PROXIMAL AND DISTAL ENDOGRAFT ATTACHMENT SITES. TREATMENT INCLUDED EXTRA-ANATOMIC AXILLOBIFEMORAL BYPASS, ENDOGRAFT EXPLANTATION, ANEURYSM SAC DEBRIDEMENT, AND DUODENAL REPAIR. INTRAOPERATIVE CULTURES FROM THE ENDOGRAFT GREW BACTEROIDES FRAGILIS AND ACTINOMYCES ISRAELII. AFTER A 2-WEEK HOSPITAL COURSE, THE PT WAS DISCHARGED ON SUPPRESSIVE ANTIBIOTICS. THE PHYSICIAN INDICATED THE LARGE SIZE OF THE ANEURYSM SAC MAY HAVE CONTRIBUTED TO THE ADF DEVELOPMENT.

    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

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| L| R