BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 1972232 · Received January 21, 2011

    Report

    Report Number
    2017233-2011-00035
    Event Type
    Injury
    Date Received
    January 21, 2011
    Date of Event
    January 20, 2011
    Report Date
    January 20, 2011
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING PAPERWORK HAS BEEN CONDUCTED. THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS. AS STATED IN THE GORE EXCLUDER AAA ENDOPROSTHESIS INSTRUCTIONS FOR USE, COMPLICATIONS THAT MAY OCCUR AND/OR REQUIRE INTERVENTION INCLUDE, BUT ARE NOT LIMITED TO, ENDOLEAK. ADD'L GORE DEVICES RELATED TO THIS EVENT: (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE PT WAS IMPLANTED WITH THREE GORE EXCLUDER AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. IT WAS NOTED THAT THE PROXIMAL NECK ANGLE MEASURED ABOUT 70 DEGREES. A POSSIBLE TYPE-2 ENDOLEAK FROM THE LUMBAR ARTERIES WAS SUSPECTED UPON COMPLETION ANGIOGRAPHY. THE PT TOLERATED THE PROCEDURE WELL. ON (B)(6) 2011, A REINTERVENTION OCCURRED TO TREAT A PROXIMAL TYPE-1 ENDOLEAK WITH SLIGHT, INDETERMINATE ANEURYSM GROWTH. A GORE EXCLUDER AAA AORTIC EXTENDER ENDOPROSTHESIS WAS PLACED. FINAL ANGIOGRAPHY CONFIRMED A TYPE-2 ENDOLEAK FROM A LUMBAR ARTERY. THE PT TOLERATED THE PROCEDURE WELL.

    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 06833498

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Hospitalization| R LASIX| (B)(4)| ASPIRIN| ATENOLOL| THYROXINE| PRAVACHOL| COUMADIN| MEDAMUCIL| ACTONEL