BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 3472274 · Received November 8, 2013

    Report

    Report Number
    2017233-2013-00721
    Event Type
    Injury
    Date Received
    November 8, 2013
    Date of Event
    October 24, 2013
    Report Date
    November 5, 2013
    Manufacturer
    W.L. GORE & ASSOCIATES,INC
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE IS BEING CONDUCTED. IMAGES WERE SENT TO GORE FOR ANALYSIS. FURTHER INFORMATION WILL BE PROVIDED. ALSO WAS IMPLANTED PXC (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE PATIENT UNDERWENT A PROCEDURE USING GORE EXCLUDER AAA ENDOPROSTHESES. IT WAS REPORTED THAT ON (B)(6) 2013, THE FOLLOW UP COMPUTED TOMOGRAPHY SCAN REVEALED THE CONTRALATERAL AND IPSILATERAL LIMBS HAVE MIGRATED AN UNKNOWN AMOUNT. ALSO, THERE APPEARS TO BE A DISTAL TYPE I ENDOLEAK. THE PHYSICIAN IS MONITORING THE PATIENT. IMAGES WERE SENT TO GORE FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    577993 GORE EXCLUDER AAA ENDOPROSTHESIS MIH W.L. GORE & ASSOCIATES,INC 8248442

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other