BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AFX

    MDR report key: 9908805 · Received March 31, 2020

    Report

    Report Number
    2031527-2020-00116
    Event Type
    Injury
    Date Received
    March 31, 2020
    Date of Event
    March 3, 2020
    Report Date
    March 3, 2020
    Manufacturer
    ENDOLOGIX
    Product Code
    MIH
    UDI-DI
    00818009013651
    PMA / PMN Number
    P040002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    PLEASE CANCEL THIS REPORT AND REMOVE FROM YOUR SYSTEM AS THIS COMPLAINT IS A DUPLICATE REPORT OF 2031527-2020-00015, PR 45479. THIS EVENT HAS BEEN PREVIOUSLY REPORTED UNDER 2031527-2020-00015, PR 45479. CORRECTION: B5: DESCRIBE EVENT OR PROBLEM HAS BEEN UPDATED.

    Description of Event or Problem · 0

    THIS EVENT IS A DUPLICATE REPORT OF 2031527-2020-00015, PR 45479. THIS COMPLAINT WAS PREVIOUSLY REPORTED UNDER 2031527-2020-00015, PR 45479.

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THIS EVENT WILL NOT BE RETURNED FOR EVALUATION AS IT REMAINS IMPLANTED IN THE PATIENT. PATIENT MEDICAL RECORDS AND IMAGING STUDIES WILL BE REQUESTED FOR FURTHER EVALUATION BY THE CLINICAL SPECIALIST. IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED. DEVICE ITERATION IS AFX WITH DURAPLY.

    Description of Event or Problem · 1

    THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT GRAFT, A SUPRARENAL STENT GRAFT EXTENSIONS AND AN OVATION IX EXTENDER STENT GRAFT EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM. THIS INITIAL PROCEDURE IS OUTSIDE THE INDICATIONS OF USE DUE TO THE USE OF ADJUNCTIVE DEVICES NOT COMPATIBLE WITH AFX SYSTEM PER THE IFU. APPROXIMATELY 2 YEARS POST INITIAL IMPLANT, DILATION AND MOVEMENT OF THE PROXIMAL EXTENSION (SUPRARENAL STENT GRAFT) WAS REPORTED. AN INTERVENTION WAS COMPLETED. THE PHYSICIAN ELECTED TO IMPLANT ANOTHER SUPRARENAL STENT GRAFT EXTENSION TO TREAT THIS EVENT. THE PATIENT IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    372134 AFX VELA SUPRARENAL MIH ENDOLOGIX A34-34/C100-O20 V 1704634-013 00818009013651

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention AFX2 BIFURCATED STENT GRAFT, LOT 1707800028| OVATION IX EXTENDER, LOT FS111516-09