BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 2004232 · Received February 21, 2011

    Report

    Report Number
    2017233-2011-00080
    Event Type
    Injury
    Date Received
    February 21, 2011
    Date of Event
    October 22, 2010
    Report Date
    February 21, 2011
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. PLEASE NOTE ADDITIONAL DEVICES INVOLVED: PXC141200/8103343 AND PXT281414/7169020.

    Description of Event or Problem · 1

    ON (B)(6) 2010, THIS PT WAS IMPLANTED WITH GORE EXCLUDER AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. ON (B)(6) 2010, THIS PT WAS TREATED FOR A LEFT ILIAC DISSECTION. ADDITIONAL GORE EXCLUDER AAA ENDOPROSTHESES WERE IMPLANTED TO TREAT THE DISSECTION. THE PT TOLERATED THE PROCEDURE AND NO FURTHER COMPLICATIONS WERE REPORTED.

    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 7779262

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R ADULT ASPIRIN| ALEVE| VITAMIN B12| LISINOPRIL| VITAMIN D| C PAP DEVI| COUMADIN| NORVAAC