BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 2234039 · Received August 29, 2011

    Report

    Report Number
    2017233-2011-00442
    Event Type
    Injury
    Date Received
    August 29, 2011
    Date of Event
    August 9, 2011
    Report Date
    August 26, 2011
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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, THE PT UNDERWENT REPAIR OF AN ABDOMINAL AORTIC ANEURYSM. WHEN USING THE GORE EXCLUDER AAA ENDOPROSTHESIS FEATURING C3 THE PHYSICIAN CONSTRAINED THE DEVICE TO REPOSITION; HOWEVER, THE DEVICE DID NOT COMPLETELY UNCONSTRAIN, ONLY PARTIALLY REOPENING. THERE WAS A PROXIMAL TYPE I ENDOLEAK AFTER DEPLOYING THE DEVICE; THEREFORE, TWO AORTIC EXTENDER COMPONENTS WERE IMPLANTED. 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 9083280

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| R BETA BLOCKER