BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 2072627 · Received April 20, 2011

    Report

    Report Number
    2017233-2011-00200
    Event Type
    Injury
    Date Received
    April 20, 2011
    Date of Event
    March 22, 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
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MFG PAPERWORK HAS BEEN CONDUCTED. THE REVIEW OF THE MFG PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THIS PT PRESENTED WITH A RUPTURED ABDOMINAL AORTIC ANEURYSM AND WAS TREATED WITH A GORE EXCLUDER AAA ENDOPROSTHESIS FEATURING C3 DELIVERY SYSTEM. FINAL ANGIOGRAPHY REVEALED NO ENDOLEAKS AT THE COMPLETION OF THE CASE. THE PT DID WELL POST-OPERATIVELY AND WAS DISCHARGED. ON (B)(6) 2011, FOLLOW UP CTA REVEALED A SIGNIFICANT TYPE I ENDOLEAK. ON (B)(6) 2011, A REINTERVENTION WAS PERFORMED WHEREBY AN AORTIC EXTENDER COMPONENT WAS IMPLANTED PROXIMALLY. THEY EXTENDED ABOUT 15-20MM PROXIMAL TO THE LOWEST RENAL ARTERY. ANGIOGRAPHY THE ENDOLEAK WAS RESOLVED. THE PT HAS DONE WELL POST-OPERATIVELY. CAUSE OF THE TYPE I ENDOLEAK WAS UNKNOWN.

    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 8005792

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| R