BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    MDR report key: 4062513 · Received September 5, 2014

    Report

    Report Number
    2953161-2014-00096
    Event Type
    Injury
    Date Received
    September 5, 2014
    Date of Event
    July 31, 2014
    Report Date
    October 31, 2014
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THIS REPORT IS TO INFORM YOU THAT THE WEIGHT NEED TO BE CORRECTED FROM (B)(6) IN THE PREVIOUS REPORT TO (B)(6) IN THIS REPORT. THE DATE OF THE EVENT HAS TO BE CORRECTED TO (B)(6) 2014. IN THIS EVENT ARE TWO ADDITIONAL DEVICES INVOLVED: PXL 161407 LOT # 043011311. PXC 141400 LOT # 03811390.

    Description of Event or Problem · 1

    ON AN UNKNOWN DATE IN 2005, THE PATIENT WAS IMPLANTED WITH A GORE® EXCLUDER® AAA ENDOPROSTHESIS TO TREAT AN ABDOMINAL AORTIC ANEURYSM. THE PATIENT HAS A HISTORY OF ANEURYSM GROWTH. IN 2012, THE ENLARGEMENT WAS MEASURED WITH 38MM AND IN (B)(6) 2014 WITH 48MM. ON (B)(6) 2014, THE PATIENT WAS ADMITTED TO THE HOSPITAL. ON (B)(6) 2014, THE ANEURYSM WAS MEASURED WITH 58MM. THE PATIENT WAS DISCHARGED WITHOUT ANY TREATMENT AND WILL BE MONITORED BY THE PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    544786 GORE® EXCLUDER® AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 03928741

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| O