BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 3221086 · Received July 3, 2013

    Report

    Report Number
    2953161-2013-00098
    Event Type
    Injury
    Date Received
    July 3, 2013
    Date of Event
    November 5, 2012
    Report Date
    June 18, 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

    THE REVIEW OF THE MFG PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS.

    Description of Event or Problem · 1

    IN A REVIEW OF PUBLISHED LITERATURE, THESE FINDINGS WERE NOTED: NAKAI M, SATO M, SATO H, SAKAGUCHI H, ET AL. MIDTERM RESULTS OF ENDOVASCULAR ABDOMINAL AORTIC ANEURYSM REPAIR: COMPARISON OF INSTRUCTION-FOR-USE (IFU) CASES AND NON-IFU CASES. (B)(4) JOURNAL OF RADIOLOGY. OF 124 PTS (104 MEN, 20 WOMEN; MEAN AGE OF PTS WITH EXCLUDER IS (B)(6); AGE RANGE (B)(6)) WITH AAA WHO UNDERWENT EVAR WITH THE ZENITH (68 PTS) OR EXCLUDER DEVICE (56) AND WERE ANALYZED, 86 WERE IFU AND 38 NON-IFU. THIS ARTICLE MENTIONS THAT 3 PTS WHO WERE IMPLANTED WITH GORE EXCLUDER AAA ENDOPROSTHESIS HAD TYPE II ENDOLEAKS AND ANEURYSM ENLARGEMENT THAT REQUIRE INTERVENTION. SPECIFIC INFO ON ONE PT WAS OBTAINED FROM NIHON GORE. ON (B)(6) 2011, THIS PT WAS IMPLANTED WITH A GORE EXCLUDER AAA ENDOPROSTHESIS TO TREAT AN ABDOMINAL AORTIC ANEURYSM. THE FINAL ANGIOGRAM REVEALED NO ENDOLEAK AND THE PHYSICIAN COMPLETED THE PROCEDURE. ON UNK DATE, APPROX ONE YEAR LATER, F/U IMAGE REVEALED A TYPE II ENDOLEAK, LEADING TO ANEURYSM ENLARGEMENT OF MORE THAN 5MM. THE ORIGIN OF THE ENDOLEAK WAS INFERIOR MESENTERIC ARTERY. ON (B)(6) 2012, AN INTERVENTION OCCURRED WHEREBY THE IMA WAS COIL EMBOLIZED. THE ENDOLEAK WAS RESOLVED AND THE PT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303515 GORE EXCLUDER AAA ENDOPROSTHESIS MIH / SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES 9173707

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| R (B)(4)| IMPLANTED: