BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AFX

    MDR report key: 8755227 · Received July 2, 2019

    Report

    Report Number
    2031527-2019-00292
    Event Type
    Injury
    Date Received
    July 2, 2019
    Date of Event
    May 3, 2019
    Report Date
    June 3, 2019
    Manufacturer
    ENDOLOGIX
    Product Code
    MIH
    PMA / PMN Number
    P040002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE EVENT WILL NOT BE RETURNED FOR EVALUATION. THE PATIENT INFORMATION AND SPECIFIC DEVICE INFORMATION FOR THIS PATIENT WAS NOT PROVIDED. AS SUCH, EVENT DETERMINATION, OFF LABEL CONDITIONS, RELATED PATIENT HARMS AND PATIENT DISPOSITION COULD NOT BE INDEPENDENTLY ASSESSED. NO ADDITIONAL INVESTIGATION OF THIS REPORTED EVENT IS PLANNED HOWEVER IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED. ENDOLOGIX WILL CONTINUE TO MONITOR THIS COMPLAINT AND SIMILAR COMPLAINTS IN THE EVENT FURTHER INVESTIGATION IS NEEDED. INSUFFICIENT DEVICE INFORMATION RECEIVED TO DETERMINE DEVICE ITERATION. DEVICE ITERATION WILL BE PROVIDED WHEN FURTHER INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    A LETTER WAS RECEIVED FROM THE DEPARTMENT OF HEALTH AND HUMAN RESOURCES (FDA) ON (B)(6) 2019 FOR THIS REPORTED EVENT MW5086822. THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE AFX ABDOMINAL AORTIC ANEURYSM STENT ON (B)(6) 2015 PER MW5086822 REPORT. APPROXIMATELY FOUR (4) YEARS POST INITIAL PROCEDURE, ON (B)(6) 2019 PER MW5086822 REPORT, A COMPONENT SEPARATION (TYPE IIIA ENDOLEAK) WAS IDENTIFIED. THERE IS LIMITED INFORMATION REGARDING THE REPORTED EVENT. THERE WAS NO INDICATED PATIENT OR PHYSICIAN IDENTIFIERS, PRODUCT INFORMATION (I.E. MODEL OR LOT/SERIAL NUMBERS), OR IF A SECONDARY INTERVENTION WAS PERFORMED TO TREAT THE COMPONENT SEPARATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    546266 AFX BIFURCATED STENT GRAFT MIH ENDOLOGIX UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other