BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 3325282 · Received August 27, 2013

    Report

    Report Number
    2953161-2013-00121
    Event Type
    Injury
    Date Received
    August 27, 2013
    Date of Event
    November 21, 2012
    Report Date
    July 30, 2013
    Manufacturer
    W. L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL DEVICES IMPLANTED AND INVOLVED IN THIS EVENT: PXT261418/03577280, PXC201000/04387829, PXA260300/8370874, PXA260300/8589685, AND PXL161407/8762650. PLEASE NOTE: THE (B)(4) 2011 INTERVENTION WAS PREVIOUSLY REPORTED UNDER MEDWATCH # 2953161-2011-00037. THE (B)(4) 2011 INTERVENTION WAS PREVIOUSLY REPORTED UNDER MEDWATCH # 2953161-2012-00088.

    Description of Event or Problem · 1

    ON (B)(6) 2006, THE PATIENT WAS IMPLANTED WITH TWO GORE EXCLUDER AAA ENDOPROSTHESIS TO TREAT AN ABDOMINAL AORTIC ANEURYSM. ON (B)(6) 2011, AN ADDITIONAL PROCEDURE WAS PERFORMED WHEREBY AN AORTIC EXTENDER COMPONENT WAS IMPLANTED TO TREAT AN UNSPECIFIED ENDOLEAK. FINAL ANGIOGRAPHY SHOWED RESOLUTION OF THE ENDOLEAK, AND THE PATIENT TOLERATED THE PROCEDURE. IN (B)(6) 2011 (EXACT DATE UNK), A COMPUTED TOMOGRAPHY ANGIOGRAM REVEALED AN UNSPECIFIED ENDOLEAK, DISTAL ANEURYSM PROGRESSION, AND ANEURYSM GROWTH OF AN UNKNOWN AMOUNT. ON (B)(6) 2011, AN AORTIC EXTENDER COMPONENT AND AN ILIAC EXTENDER COMPONENT WERE IMPLANTED TO TREAT THE ENDOLEAK AND DISEASE PROGRESSION. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2012, AN AORTIC EXTENDER COMPONENT WAS IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418443 GORE EXCLUDER AAA ENDOPROSTHESIS MIH/ SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES 8589685

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Hospitalization| R AMLODIPINE| ATENOLOL| LIPITOR| HYDROCHLOROTHIAZID (HTCZ)| ASPIRIN