BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 1910372 · Received November 24, 2010

    Report

    Report Number
    2953161-2010-00215
    Event Type
    Injury
    Date Received
    November 24, 2010
    Date of Event
    December 1, 2009
    Report Date
    November 24, 2010
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING PAPERWORK HAS BEEN CONDUCTED. THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS.

    Description of Event or Problem · 1

    ON (B)(6), 2007, THE PT WAS IMPLANTED WITH TWO GORE EXCLUDER AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. ON (B)(6), 2009, A COMPUTED TOMOGRAPHY REVEALED A PROXIMAL TYPE I ENDOLEAK. ON (B)(6), 2009, A F/U COMPUTED TOMOGRAPHY REVEALED A PERSISTENT PROXIMAL TYPE I ENDOLEAK. ON (B)(6), 2010, THE PT WAS IMPLANTED WITH A GORE EXCLUDER AAA ENDOPROSTHESIS AORTIC EXTENDER COMPONENT TO TREAT THE PROXIMAL TYPE I ENDOLEAK. THE ENDOLEAK WAS RESOLVED AND NO FURTHER COMPLICATIONS WERE REPORTED.

    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 WLG425 05262025

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R ALBUTEROL| PLAVIX| CALCIUM PLUS VITAMIN D| MAXZIDE| LISINOPRIL| MULTI-VITAMIN| CRESTOR| ASPIRIN| TOPROL| NIASPIN| CHLORPHENIRAMINE| SINGULAIR