BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 3347733 · Received September 10, 2013

    Report

    Report Number
    2017233-2013-00613
    Event Type
    Injury
    Date Received
    September 10, 2013
    Date of Event
    May 23, 2013
    Report Date
    August 16, 2013
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS AN EVENT DATE HAS NOT BEEN PROVIDED, THE DATE OF EVENT WILL BE NOTED AS 5-23/2013 (THE PUBLICATION DATE NOTED IN THE CITED WORK). A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE PERFORMED AS THE LOT NUMBER WAS NOT AVAILABLE. THE ROOT CAUSE OF THE LIMB OCCLUSION COULD NOT BE DETERMINED WITH THE PROVIDED INFO. HOSHINA KATSUYUKI, TAKAFUMI AKAI, TOSHIO TAKAYAMA, MASAAKI KATO, TATSU NAKAZAWA, HIROYUKI OKAMOTO, KUNIHIRO SHIGEMATSU AND TETSURO MIYATA. "OUTCOMES AND MORPHOLOGIC CHANGES AFTER ENDOVASCULAR REPAIR FOR ABDOMINAL AORTIC ANEURYSMS WITH A SEVERELY ANGULATED NECK." CIRCULATION JOURNAL AUG 2013; 77: 1996-2002.

    Description of Event or Problem · 1

    AN ARTICLE IN THE CIRCULATION JOURNAL REPORTS A RETROSPECTIVE ANALYSIS OF 190 PTS WHO UNDERWENT ENDOVASCULAR REPAIR OF ABDOMINAL AORTIC ANEURYSMS WITH SEVERELY ANGULATED NECKS BETWEEN APRIL 2008 AND SEPTEMBER 2011. THE GORE EXCLUDER AAA ENDOPROSTHESIS WAS IMPLANTED IN 34 OF THE PTS. AMONG THE 34 PTS, 29 SHOWED IMMEDIATE STRAIGHTENING OF THE NECK ANGLE AFTER THE OPERATION, WITH EIGHT SUBSEQUENTLY EXHIBITING RECOIL. THIS ARTICLE DESCRIBES A PT WHO POST-OPERATIVELY PRESENTED WITH LIMB OCCLUSION, WHICH WAS SUCCESSFULLY TREATED BY A CROSS-OVER BYPASS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    452492 GORE EXCLUDER AAA ENDOPROSTHESIS MIH/SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R