BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 2070255 · Received April 18, 2011

    Report

    Report Number
    2953161-2011-00095
    Event Type
    Injury
    Date Received
    April 18, 2011
    Date of Event
    March 25, 2011
    Report Date
    April 18, 2011
    Manufacturer
    W. L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE PT UNDERWENT REPAIR OF AN ABDOMINAL AORTIC ANEURYSM. THE PT HAD EXCESSIVE VESSEL TAPER AND THE AORTA WAS SEVERELY TORTUOUS NEAR THE LEFT RENAL ARTERY. AN AORTIC EXTENDER COMPONENT WAS IMPLANTED AND BALLOONED WITH A CODA BALLOON. AN ANGIOGRAM PERFORMED REVEALED AN AORTIC RUPTURE NEAR THE RENAL ARTERY. THE PT WAS CONVERTED TO OPEN REPAIR WHERE ALL GORE EXCLUDER AAA ENDOPROSTHESES WERE EXPLANTED AND DISCARDED. 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 8356492

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Hospitalization| R PXC201000/(B)(4)| PXT281412/(B)(4)| PXC201200/(B)(4)