BEUDAMED
    FDA Adverse Event Death Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 1741310 · Received June 25, 2010

    Report

    Report Number
    2017233-2010-00303
    Event Type
    Death
    Date Received
    June 25, 2010
    Date of Event
    May 28, 2010
    Report Date
    June 25, 2010
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD - A REVIEW OF THE MANUFACTURING RECORDS HAS BEEN CONDUCTED. RESULTS - THE MANUFACTURING RECORDS REVIEW VERIFIED THAT THE LOTS MET ALL PRE-RELEASE SPECIFICATIONS.

    Description of Event or Problem · 1

    ON (B) (6) 2005, THE PT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM WITH GORE EXCLUDER AAA ENDOPROSTHESES. FOLLOW UP IMAGING THROUGH 2007, SHOWED DEVELOPMENT OF A LEFT COMMON ILIAC ARTERY (CIA) ANEURYSM, WHICH LED TO LOSS OF DISTAL SEAL AND A TYPE I ENDOLEAK. HE WAS LOST TO FOLLOW UP AFTER 2007. LATE AT NIGHT ON (B) (6) 2010, THE PT PRESENTED WITH A RUPTURED LEFT CIA ANEURYSM. BY EARLY THE NEXT DAY, HE UNDERWENT SURGICAL REPAIR OF THE RUPTURE, BUT EXPIRED DUE TO BLOOD LOSS.

    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 WLG325 03690231

    Patients

    Seq Age Sex Outcome Treatment
    1 Death