BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    MDR report key: 7162894 · Received January 3, 2018

    Report

    Report Number
    2953161-2018-00001
    Event Type
    Injury
    Date Received
    January 3, 2018
    Date of Event
    December 4, 2017
    Report Date
    December 6, 2017
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LOT/SERIAL# (B)(4): UDI (B)(4). THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS. ACCORDING TO THE GORE® EXCLUDER® AAA ENDOPROSTHESIS INSTRUCTIONS FOR USE, ADVERSE EVENTS WHICH MAY OCCUR AND REQUIRE INTERVENTION INCLUDE ENDOLEAK. (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2017, THE PATIENT WAS BEING TREATED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT IMAGES TAKEN ON (B)(6) 2017, REVEALED THE PREVIOUSLY IMPLANTED PXC141200/15801886 ENDOGRAFT HAD LOST SEAL. A REINTERVENTION OCCURRED ON (B)(6) 2017. IT WAS REPORTED THERE WAS A DISTAL TYPE I ENDOLEAK ON THE PXC141200/15801886 DEVICE. THE PHYSICIAN EXTENDED THE LIMB WITH AN ADDITIONAL PXC ENDOPROSTHESIS. THE ENDOLEAK WAS RESOLVED, THERE WAS SEAL AND THE PATIENT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3374 GORE® EXCLUDER® AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 15801886

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| R