BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 2921926 · Received January 11, 2013

    Report

    Report Number
    2017233-2013-00017
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    December 14, 2012
    Report Date
    December 20, 2012
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REVIEW OF THE MFG PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS. ADDITIONAL DEVICES IMPLANTED AND INVOLVED IN THIS EVENT: PXC201000/7367340 AND PXC181200/06171053.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE PT UNDERWENT TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM WITH THREE GORE EXCLUDER AAA ENDOPROSTHESES. IT WAS REPORTED THAT ON (B)(6) 2012, F/U IMAGING IDENTIFIED A TYPE II ENDOLEAK FROM A LUMBAR ARTERY WITH ANEURYSM ENLARGEMENT FROM 5 TO 5.5 CM. NO FURTHER ADVERSE EVENTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18092 GORE EXCLUDER AAA ENDOPROSTHESIS MIH / SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 06670904

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization| R SIMVASTATIN| LEVOTHYROXINE SODIUM| ADVAIR| AMLODIPINE| ASPIRIN| ENALAPRIL