BEUDAMED
    FDA Adverse Event Death Summary report: N

    AFX

    MDR report key: 5365164 · Received January 13, 2016

    Report

    Report Number
    2031527-2016-00014
    Event Type
    Death
    Date Received
    January 13, 2016
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    PMA / PMN Number
    P040002
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE THE INCIDENT SAMPLE HAS NOT BEEN RECEIVED FOR EVALUATION. IF THE SAMPLE IS RECEIVED OR IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED. CONCOMITANT MEDICAL DEVICE: MODEL BIFURCATED BA25-110/I20-30, LOT: 1200177-018, REL. DATE: (B)(6) 2013, EXP. DATE: 10/31/2014.

    Additional Manufacturer Narrative · 1

    BASED UPON THE CLINICAL EVALUATION CONFIRMED TYPE 3A ENDOLEAK, STENT SEPARATION, STENT MIGRATION AND A RUPTURE. THE EVENT IS NOT A DESIGN OR MANUFACTURING RELATED ISSUE. THE ROOT CAUSE IS INCONCLUSIVE, THERE IS NOT ENOUGH INFORMATION TO DETERMINE THE ROOT CAUSE OF THE REPORTED EVENT. CONTRIBUTING FACTORS INCLUDE OFF LABEL USE, PATIENT ANATOMY, AND NON-COMPLIANCE WITH RECOMMENDED FOLLOW-UPS.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD A PROCEDURE ON (B)(6) /2014 WITH A BIFURCATED, AND A SUPRARENAL AORTIC EXTENSION. POST 60 DAY A COMPUTED TOMOGRAPHY WAS DONE AFTER THE INITIAL IMPLANT, AND EVERYTHING LOOKED SEALED. REPORTEDLY, THE PATIENT CAME IN EMERGENTLY WITH A RUPTURE AAA AND THERE WAS A SEPARATION BETWEEN THE COMPONENTS CREATING AN ENDOLEAK 3A. THE PHYSICIAN ELECTED TO EXPLANT THE DEVICES AND PATIENT WAS STABLE AFTER PROCEDURE. HOWEVER, ON (B)(6) 2015 THE PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21464 AFX AORTO UNI-ILIAC [SUPRARENAL] MIH ENDOLOGIX, INC. A28-28/C95-O20 V 1203994005

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Death