BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 3021550 · Received March 12, 2013

    Report

    Report Number
    2953161-2013-00037
    Event Type
    Injury
    Date Received
    March 12, 2013
    Date of Event
    February 21, 2013
    Report Date
    February 21, 2013
    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

    RESULTS - THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THESE LOTS MET ALL PRE-RELEASE SPECIFICATIONS. CONCLUSIONS - PER THE GORE EXCLUDER AAA ENDOPROSTHESIS INSTRUCTIONS FOR USE (IFU), THE AORTIC EXTENDER ENDOPROSTHESIS COMPONENTS: THE AORTIC EXTENDER ENDOPROSTHESES ARE INTENDED TO BE USED AFTER DEPLOYMENT OF THE GORE EXCLUDER AAA ENDOPROSTHESIS. THESE EXTENSIONS ARE INTENDED TO BE USED WHEN ADDITIONAL LENGTH AND/OR SEALING FOR ANEURYSMAL EXCLUSION IS DESIRED. FURTHERMORE, PER THE IFU THE SAFETY AND EFFECTIVENESS OF THE GORE EXCLUDER AAA ENDOPROSTHESIS HAVE NOT BEEN EVALUATED IN THE FOLLOWING PATIENT POPULATIONS: LEAKING: PENDING RUPTURE OR RUPTURED ANEURYSMS AND REVISION OF PREVIOUSLY PLACED STENT GRAFTS.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE PATIENT WAS IMPLANTED WITH TWO GORE EXCLUDER AORTIC EXTENDER ENDOPROSTHESES TO TREAT A SACULAR INFRARENAL AORTIC ANEURYSM. ON (B)(6) 2013, FOLLOW-UP IMAGING REVEALED A POSSIBLE RUPTURED ANEURYSM. ON (B)(6) 2013, THE PATIENT WAS EMERGENTLY IMPLANTED WITH TWO GORE EXCLUDER AAA ENDOPROSTHESES TO TREAT THE POSSIBLE ANEURYSM RUPTURE. THE POSSIBLE RUPTURE WAS RESOLVED, AND THE PATIENT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104584 GORE EXCLUDER AAA ENDOPROSTHESIS MIH / SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES 10717527

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention PXA230300/10210745