BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    MDR report key: 4213156 · Received October 30, 2014

    Report

    Report Number
    2017233-2014-00562
    Event Type
    Injury
    Date Received
    October 30, 2014
    Date of Event
    November 20, 2013
    Report Date
    November 7, 2014
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    W.L. GORE & ASSOCIATES, INC. (GORE) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS.

    Additional Manufacturer Narrative · 1

    PLEASE NOTE, ADDITIONAL DEVICES IMPLANTED IN THIS PATIENT AND INVOLVED IN THIS EVENT INCLUDE: PLC181000 LOT # 11441813, PLC231400 LOT # 11535877.

    Description of Event or Problem · 1

    ON (B)(6) 2013 A PATIENT IN THE (B)(6) STUDY WAS IMPLANTED WITH A GORE® EXCLUDER® AAA ENDOPROSTHESIS FEATURING C3® DELIVERY SYSTEM TO TREAT AN ABDOMINAL AORTIC ANEURYSM. THE PATIENT WAS DISCHARGED AT (B)(6) 2013. ON (B)(6) 2013 THE PATIENT PRESENTED WITH A BILATERAL TYPE I ENDOLEAK DISTAL. ON (B)(6) 2013 THE PATIENT WAS IMPLANTED WITH 2 GORE® EXCLUDER® AAA ENDOPROSTHESIS COMPONENTS IN THE LEFT LEG TO AND 2 GORE® VIABAHN® ENDOPROSTHESIS IN THE RIGHT LEG TO TREAT THE BILATERAL TYPE I ENDOLEAK DISTAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    697314 GORE® EXCLUDER® AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 11488223

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization| R