BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AFX SYSTEM

    MDR report key: 3022104 · Received March 26, 2013

    Report

    Report Number
    2031527-2013-00048
    Event Type
    Injury
    Date Received
    March 26, 2013
    Date of Event
    February 26, 2013
    Report Date
    February 26, 2013
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    PMA / PMN Number
    P040002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ENDOLOGIX CONTINUES TO INVESTIGATE THE REPORTED EVENT. ENDOLOGIX WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. DEVICE NOT RETURNED TO MANUFACTURER.

    Additional Manufacturer Narrative · 1

    BASED UPON THE REVIEW OF LOT RECORDS, WORK ORDERS, AND PRIOR REPORTS NO ISSUES WITH THE LOT WERE NOTED. ACTUAL DEVICE WAS NOT RETURNED HENCE NO DEVICE EVALUATION WAS PERFORMED. NO CONCLUSIONS COULD BE DRAWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TWELVE MONTHS POST-IMPLANT OF A BIFURCATED DEVICE AND SUPRARENAL AORTIC EXTENSION, A FOLLOW-UP COMPUTED TOMOGRAPHY SCAN REVEALED A SLIGHT IN-FOLDING OF THE SUPRARENAL AORTIC EXTENSION WITH NO ENDOLEAK. REPORTEDLY, THE PATIENT PRESENTED WITH SEVERE ANGULATION. THE PHYSICIAN PERFORMED A SNORKEL PROCEDURE AND IMPLANTED AN INFRARENAL AORTIC EXTENSION AND SUPRARENAL AORTIC EXTENSION. IT WAS REPORTED THE PATIENT TOLERATED THE PROCEDURE WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123245 AFX SYSTEM SUPRARENAL PROXIMAL EXTENSION STENT GRAFT MIH ENDOLOGIX, INC. A34-34/C100-O20 W11-5120-002

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention