BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 2250995 · Received September 12, 2011

    Report

    Report Number
    2953161-2011-00194
    Event Type
    Injury
    Date Received
    September 12, 2011
    Date of Event
    August 16, 2011
    Report Date
    September 13, 2011
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS. ACCORDING TO THE GORE EXCLUDER AAA ENDOPROSTHESIS INSTRUCTIONS FOR USE THE (B)(4) IS INTENDED TO TREAT PTS WITH AN AORTIC DIAMETER OF 24-26MM.

    Description of Event or Problem · 1

    ON (B)(6) 2011 THE PT WAS BEING TREATED WITH THE GORE EXCLUDER AAA ENDOPROSTHESIS. THE FINAL ANGIOGRAM SHOWED A PROXIMAL TYPE I ENDOLEAK DUE TO POOR WALL APPOSITION SO THE PHYSICIAN USED A COOK CODA BALLOON TO MODEL THE PROXIMAL END OF THE TRUNK IPSILATERAL LEG COMPONENT. AFTER THE BALLOONING THE PTS BLOOD PRESSURE DROPPED, BUT STABILIZED. LATER THAT DAY A CT SHOWED A DISSECTION PROXIMAL TO THE TRUNK IPSILATERAL LEG COMPONENT AND THE PT WAS CONVERTED TO OPEN SURGICAL REPAIR.

    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 8678443

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| O| R PIGTAIL CATHETER| COOK CODA BALLOON| TERUMO WIRE| LUNDERQUIST GUIDEWIRE