BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 1873049 · Received October 14, 2010

    Report

    Report Number
    2953161-2010-00187
    Event Type
    Injury
    Date Received
    October 14, 2010
    Date of Event
    September 28, 2010
    Report Date
    October 13, 2010
    Manufacturer
    W. L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: A REVIEW OF THE MFG PAPERWORK HAS BEEN CONDUCTED. RESULTS: THE REVIEW OF THE MFG PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS. CONCLUSIONS: ACCORDING TO THE GORE EXCLUDER AAA ENDOPROSTHESIS INSTRUCTIONS FOR USE, THE GORE EXCLUDER AAA ENDOPROSTHESIS AORTIC EXTENDER COMPONENT PROVIDES AN EXTENSION OF THE LEADING END OF THE TRUNK-IPSILATERAL LEG COMPONENT WHEN ADD'L LENGTH AND / OR SEALING FOR ANEURISMAL EXCLUSION IS DESIRED.

    Description of Event or Problem · 1

    ON (B)(6), 2005, THE PATIENT WAS IMPLANTED WITH THREE GORE EXCLUDER AAA ENDOPROSTHESES TO REPAIR AN ABDOMINAL AORTIC ANEURYSM, AND ONE AORTIC EXTENDER COMPONENT TO REPAIR A DISTAL COMMON ILIAC ANEURYSM. ON (B)(6), 2010, THE PT UNDERWENT A F/U COMPUTED TOMOGRAPHY WHERE A SPACE BETWEEN THE AORTIC EXTENDER COMPONENT AND A CONTRALATERAL LEG COMPONENT WAS NOTED. THERE WAS NO ENDOLEAK OR ANEURYSM GROWTH. ON (B)(6), 2010, THE PT UNDERWENT A REINTERVENTION WHERE A CONTRALATERAL LEG COMPONENT WAS IMPLANTED, BRIDGING THE ORIGINALLY IMPLANTED CONTRALATERAL LEG COMPONENT AND THE AORTIC EXTENDER COMPONENT. THE PT TOLERATED THE PROCEDURE.

    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 03782648

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization| R HYDROCODONE| METOPROLOL| OMEPRAZOLE| PREDNISONE| THE PT'S MEDICATIONS INCLUDE: POLY IRON| GLUCOSAMINE