BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOLOGIX BIFURCATED AAA GRAFT

    MDR report key: 11998968 · Received June 14, 2021

    Report

    Report Number
    MW5101881
    Event Type
    Injury
    Date Received
    June 14, 2021
    Date of Event
    June 10, 2021
    Report Date
    June 10, 2021
    Manufacturer
    ENDOLOGIX LLC.
    Product Code
    MIH
    UDI-DI
    1047071005
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    DE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PATIENT WILL REQUIRE RE OPERATIVE INTERVENTION DUE TO RECALLED PRODUCT. HE HAD ENDOVASCULAR AAA REPAIR (B)(6) 2013 WITH ENDOLOGIX ENDOVASCULAR STENT. HE HAD YEARLY F/U PER GUIDELINES AND NOW HAS RAPIDLY INCREASED SIZE OF AAA NEW TYPE 3 ENDOLEAK REQUIRING REPLACEMENT OF GRAFT TO PREVENT AAA RUPTURE. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    886424 ENDOLOGIX BIFURCATED AAA GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH ENDOLOGIX LLC. 1047071005

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention