BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    MDR report key: 5533490 · Received March 29, 2016

    Report

    Report Number
    2017233-2016-00292
    Event Type
    Injury
    Date Received
    March 29, 2016
    Date of Event
    June 2, 2014
    Report Date
    March 11, 2016
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THE LOT(S) MET ALL PRE-RELEASE SPECIFICATIONS.(B)(4). ADDITIONAL AAA® DEVICES INCLUDED IN THIS REPORT: PXC121000/9212398 (B)(4); PXA230300/9078503 (B)(4); PXA230300/9078502 (B)(4).ACCORDING TO THE GORE® EXCLUDER® AAA ENDOPROSTHESIS INSTRUCTIONS FOR USE (IFU), USERS ARE MADE AWARE OF THE RISKS ASSOCIATED WITH TYPE II ENDOLEAKS AND ARE INSTRUCTED TO CONSIDER THE RISKS AND BENEFITS DISCUSSED IN THE IFU FOR EACH PATIENT BEFORE USING THE DEVICES. ADDITIONALLY, THE IFU WARNS THAT ADVERSE EVENTS THAT MAY OCCUR AND / OR REQUIRE INTERVENTION INCLUDE, BUT ARE NOT LIMITED TO ENDOLEAK, ANEURYSM ENLARGEMENT.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE PATIENT WAS TREATED WITH GORE EXCLUDER AAA ENDOPROSTHESIS FEATURING C3 DELIVERY SYSTEM. IT WAS REPORTED THAT THE PATIENT HAD A HIGHLY ANGULATED AORTIC NECK (OUTSIDE OF IFU). IT WAS REPORTED THAT ON (B)(6), 2014, A REINTERVENTION WAS PERFORMED TO TREAT AN ENDOLEAK (UNSPECIFIED), A PXC121000 AND SOME COILS WERE ADDED. THE PATIENT TOLERATED THE PROCEDURE. NO ADDITIONAL INFORMATION IS AVAILABLE ON THIS CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    188349 GORE® EXCLUDER® AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 9789473

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Hospitalization| R