BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 2221249 · Received August 17, 2011

    Report

    Report Number
    2017233-2011-00428
    Event Type
    Injury
    Date Received
    August 17, 2011
    Date of Event
    June 30, 2011
    Report Date
    August 17, 2011
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, 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. ADDITIONAL DEVICE: (B)(4).

    Description of Event or Problem · 1

    ON (B)(6), 2006, THE PT WAS IMPLANTED WITH FOUR GORE EXCLUDER AAA ENDOPROSTHESES TO REPAIR AN ABDOMINAL AORTIC ANEURYSM. ON (B)(6), 2008, THE PT UNDERWENT A FOLLOW-UP COMPUTED TOMOGRAPHY THAT REVEALED AN UNSPECIFIED ENDOLEAK WITH THE ANEURYSM MEASURING 75.1 MM X 75.6 MM. ON (B)(6), 2011, THE PT UNDERWENT A FOLLOW-UP COMPUTED TOMOGRAPHY THAT REVEALED A POSSIBLE TYPE II ENDOLEAK AND A DISTAL TYPE I ENDOLEAK WITH THE ANEURYSM MEASURING 83.5 MM X 86.1 MM. ON (B)(6), 2011, THE PT UNDERWENT A REINTERVENTION WHERE THE PT WAS IMPLANTED WITH THREE ADDITIONAL GORE EXCLUDER AAA ENDOPROSTHESES. THE DISTAL TYPE I ENDOLEAK WAS RESOLVED. 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 04345396

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| R TRAZODONE| FLUOXETINE| SIMVASTATIN