BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 2237890 · Received September 1, 2011

    Report

    Report Number
    2017233-2011-00452
    Event Type
    Injury
    Date Received
    September 1, 2011
    Date of Event
    August 9, 2011
    Report Date
    September 1, 2011
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING PAPERWORK HAS BEEN CONDUCTED. THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THE LOTS MET ALL PRE-RELEASE SPECIFICATIONS. ADDITIONAL DEVICES: 06854407/(B)(4), 8893483/(B)(4).

    Description of Event or Problem · 1

    ON (B)(6), 2011, THE PT UNDERWENT THE FIRST PART OF A STAGED PROCEDURE FOR A JUXTARENAL ANEURYSM INVOLVING THE LEFT RENAL ARTERY WHERE TWO GORE EXCLUDER AAA ENDOPROSTHESES WERE IMPLANTED. ON (B)(6), 2011, THE PT UNDERWENT THE SECOND PART OF THE PROCEDURE FOR AN INFRARENAL ABDOMINAL AORTIC ANEURYSM AND BILATERAL ILIAC ANEURYSMS, AND WAS IMPLANTED WITH A GORE EXCLUDER AAA ENDOPROSTHESIS FEATURING C3 AND FIVE ADDITIONAL GORE EXCLUDER AAA ENDOPROSTHESES. ON (B)(6), 2011, THE PT UNDERWENT A FOLLOW-UP COMPUTED TOMOGRAPHY THAT REVEALED BOTH A PROXIMAL AND DISTAL TYPE I ENDOLEAK FROM DEVICES IMPLANTED IN (B)(6), 2011. ON (B)(6), 2011, THE PT UNDERWENT A REINTERVENTION WHERE THREE ADDITIONAL GORE EXCLUDER AAA ENDOPROSTHESES WERE IMPLANTED. FINAL ANGIOGRAPHY REVEALED NO ENDOLEAKS AND 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 WLG425 8856306

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R PLAVIX| LIPITOR| METOPROLOL| PRILOSEC| PROZAC| AMLODIPINE| THE PATIENT IS ALSO ON DIALYSIS| CLONIDINE| ASPIRIN