BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 3092344 · Received April 29, 2013

    Report

    Report Number
    2017233-2013-00266
    Event Type
    Injury
    Date Received
    April 29, 2013
    Date of Event
    April 17, 2013
    Report Date
    April 17, 2013
    Manufacturer
    W.L. GORE & ASSOCIATES,INC
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    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

    ON (B)(6) 2012, THIS PT WAS IMPLANTED WITH TWO GORE EXCLUDER AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. ON AN UNK DATE, IMAGING SHOWED A PROXIMAL TAPE I ENDOLEAK, REPORTEDLY DUE TO PROXIMAL NECK ANGULATION (AMOUNT UNK) AND INADEQUATE NECK LENGTH (APPROX 1 CM) BELOW THE RENAL ARTERIES. IT WAS REPORTED IT IS UNK IF ANEURYSM ENLARGEMENT OCCURRED AS A RESULT OF THE ENDOLEAK. ON (B)(6) 2013 AN AORTIC EXTENDER COMPONENT WAS IMPLANTED TO TREAT THE PROXIMAL TYPE I ENDOLEAK. FINAL ANGIOGRAPHY SHOWED RESOLUTION OF THE ENDOLEAK, AND THE PT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184714 GORE EXCLUDER AAA ENDOPROSTHESIS MIH/SYSTE, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES,INC 10613913

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| R COZAAR| CRESTOR| VITAMIN D| COREG| ASPIRIN| LANOXIN