BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 1780873 · Received July 29, 2010

    Report

    Report Number
    2017233-2010-00354
    Event Type
    Injury
    Date Received
    July 29, 2010
    Date of Event
    June 1, 2010
    Report Date
    July 28, 2010
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MFG RECORDS FOR THE DEVICE WILL BE CONDUCTED. IMAGES WERE SENT TO GORE FOR ANALYSIS. UPON THE IMAGING EVAL, POST - IMPLANT IMAGES TAKEN (B)(6) 2010, SHOW CONTRAST POOLING OUTSIDE THE IMPLANTED DEVICES. THERE APPEARS TO BE POOR WALL APPOSITION OF THE PROXIMAL END OF THE TRUNK-IPSILATERAL LEG COMPONENT ALONG THE POSTERIOR WALL OF THE PROXIMAL NECK. THERE APPEARS TO BE CONTRAST SURROUNDING THE PROXIMAL END OF THE TRUNK. THIS CONTRAST APPEARS TO COMMUNICATE WITH CONTRAST POOLING WITHIN THE ANEURISMAL SAC. THE ORIGIN OF CONTRAST POOLING WITHIN THE SAC CANNOT BE CONFIRMED WITH AVAILABLE IMAGES. ACCORDING TO THE GORE EXCLUDER AAA ENDOPROSTHESIS INSTRUCTIONS FOR USE, ADVERSE EVENTS THAT MAY OCCUR INCLUDE, BUT ARE NOT LIMITED TO ENDOLEAK. ALSO, ACCORDING TO THE GORE EXCLUDER AAA ENDOPROSTHESIS INSTRUCTIONS FOR USE, TYPE II ENDOLEAKS ARE A KNOWN RISK FACTOR FOR ENDOVASCULAR TREATMENT OF ABDOMINAL AORTIC ANEURYSMS. ALSO WERE IMPLANTED. PXC201200/06471986 AND PXC201400/7436620.

    Description of Event or Problem · 1

    ON (B)(6) 2010, THIS PT WAS IMPLANTED WITH THREE GORE EXCLUDER AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. CONTROL ANGIOGRAPHY SHOWED WHAT WAS INTERPRETED TO BE A TYPE II ENDOLEAK. FROM IMAGES TAKEN (B)(6) 2010, THE PHYSICIAN SUSPECTS A POSSIBLE TYPE I OR TYPE II ENDOLEAK. THE PT IS CURRENTLY BEING MONITORED BY THE PHYSICIAN.

    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 WLG325 06731524

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Hospitalization| O