BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOLOGIX AFX

    MDR report key: 14622308 · Received June 6, 2022

    Report

    Report Number
    MW5110135
    Event Type
    Injury
    Date Received
    June 6, 2022
    Date of Event
    May 27, 2022
    Report Date
    June 2, 2022
    Manufacturer
    ENDOLOGIX LLC.
    Product Code
    MIH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ENDOLOGIX AFX FAILURE; THE PATIENT IS S/P REPAIR OF AAA IN 2012 USING AN ENDOLOGIX AFX DEVICE. THE PATIENT PRESENTED TO THE ED WITH ACUTE ABDOMINAL PAIN AND CT SCAN DEMONSTRATING RUPTURED ANEURYSM AND TYPE III ENDOLEAK. HE WAS TAKEN EMERGENTLY TO THE OPERATING ROOM AND WAS REPAIRED WITH A MEDTRONIC GRAFT. DURING THE COURSE HE HAD PEA ARREST INTRA-OP WHICH RESPONDED TO RESUSCITATION. THE PATIENT WAS TRANSFERRED TO THE ICU INTUBATED POSTOPERATIVELY AND WAS ABLE TO BE EXTUBATED THE SAME DAY. HE REQUIRED SUPPLEMENTAL OXYGEN UNTIL POSTOPERATIVE DAY 4. HE WAS DISCHARGED TO HOME POSTOPERATIVE DAY 5. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2217728 ENDOLOGIX AFX SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH ENDOLOGIX LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male Hospitalization| L MEDTRONIC GRAFT