BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOLOGIX AAA DEVICE

    MDR report key: 7340872 · Received March 14, 2018

    Report

    Report Number
    MW5075873
    Event Type
    Injury
    Date Received
    March 14, 2018
    Date of Event
    September 1, 2016
    Report Date
    March 14, 2018
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PATIENT STATES THAT HE BEGAN FEELING SICK WITH STOMACH PAIN IN (B)(4) OF 2016 AND HAD A CT SCAN THAT WAS PERFORMED AFTER GOING TO THE HOSPITAL WHICH REVEALED THERE WAS A LEAK OF THE ANEURYSM IMPLANT THAT WAS ORIGINALLY IMPLANTED TO TREAT AN ABDOMINAL ANEURYSM. THE PATIENT SAID THAT THE SURGEON DID A REVISION SURGERY TO FIX THE ISSUE, HOWEVER 6 WEEKS LATER HAD SAME RECURRING ISSUE WITH THE IMPLANT AND HAD TO GO IN FOR ANOTHER REVISION SURGERY. THE PATIENT GOES ON TO STATE THAT THE DEVICE BEGAN TO LEAK A THIRD TIME IN (B)(6) OF 2018, AND VISITED A DIFFERENT SURGEON THAT WAS NOT ABLE TO RECTIFY THE ISSUE EITHER. PATIENT ALSO STATES THAT THERE WAS A POSSIBLE RECALL THAT HE WAS LOOKING INTO FOR HIS DEVICE THAT WAS ACTUALLY FOR THE PROBLEM OF LEAKAGE IN THESE IMPLANTS, THE ONLY ISSUE HOWEVER IS THE FACT THE PATIENT ISN'T AWARE OF WHETHER THE SPECIFIC DEVICE IN HIM IS AFFECTED BY THIS RECALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    180722 ENDOLOGIX AAA DEVICE SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM MIH ENDOLOGIX, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other| R