BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 3001647 · Received March 8, 2013

    Report

    Report Number
    2017233-2013-00125
    Event Type
    Injury
    Date Received
    March 8, 2013
    Date of Event
    May 2, 2012
    Report Date
    February 26, 2013
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER INFORMATION WAS REQUESTED. A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE IS BEING CONDUCTED. ALSO WAS IMPLANTED (B)(4). THE DATE OF THE ANEURYSM ENLARGEMENT AND THE REINTERVENTION IS UNKNOWN, THE DATE OF HOSPITALIZATION (B)(6) 2012 WILL BE USED AS A DATE OF EVENT.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE PATIENT WAS IMPLANTED WITH A GORE EXCLUDER AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. THE COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) SHOWED THE ANEURYSM DIAMETER WAS 58MM. THE PATIENT TOLERATED THE INITIAL PROCEDURE. ON (B)(6) 2011, THE FOLLOW-UP EXAM SHOWED THAT THE ANEURYSM SIZE WAS 58MM. ON (B)(6) 2012, THE PATIENT WAS HOSPITALIZED FOR ANEURYSM ENLARGEMENT. ON AN UNKNOWN DATE IN (B)(6) 2012, THE PATIENT UNDERWENT AN EMBOLIZATION PROCEDURE TO FIX A TYPE II ENDOLEAK FROM LUMBAR ARTERIES AND THE ANEURYSM ENLARGEMENT. ON (B)(6) 2012, THE CTA SHOWED THAT THE DIAMETER OF ANEURYSM WAS 59.3MM. ON (B)(6) 2012, THE SIZE OF ANEURYSM WAS 53MM. FURTHER INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    99426 GORE EXCLUDER AAA ENDOPROSTHESIS MIH / SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 8719842

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| R