BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 2211316 · Received August 2, 2011

    Report

    Report Number
    2953161-2011-00171
    Event Type
    Injury
    Date Received
    August 2, 2011
    Date of Event
    July 20, 2011
    Report Date
    August 2, 2011
    Manufacturer
    W. L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, 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. AFTER THE TRUNK-IPSILATERAL LEG COMPONENT WAS IMPLANTED, THE PHYSICIAN FELT THAT THE LEFT RENAL MAY BE PARTIALLY COVERED; HOWEVER, HE WAS UNABLE TO CONFIRM THIS. A BOSTON SCIENTIFIC STENT WAS IMPLANTED INTO THE RENAL. BLOOD FLOW WAS FINE. 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 8178456

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R PATIENT MEDICATIONS INCLUDE ASPIRIN AND| FISH OIL