BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AFX

    MDR report key: 8805500 · Received July 18, 2019

    Report

    Report Number
    2031527-2019-00322
    Event Type
    Injury
    Date Received
    July 18, 2019
    Date of Event
    June 18, 2019
    Report Date
    June 18, 2019
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    UDI-DI
    00818009012630
    PMA / PMN Number
    P040002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CLINICAL ASSESSMENT WAS COMPLETED BASED ON THE RECEIVED MEDICAL RECORDS. THE REPORTED TYPE IB ENDOLEAK FROM BILATERAL COMMON ILIAC ARTERIES, SECONDARY ENDOVASCULAR PROCEDURE WAS CONFIRMED. DEVICE, USER, PROCEDURE OR ANATOMY RELATEDNESS OF THE FOR THE DISTAL LOSS OF SEAL COULD NOT BE DETERMINED DUE TO THE LACK OF A PRE EVAS CT STUDY. THE FINAL PATIENT STATUS WAS REPORTED BEING STABLE. THE MANUFACTURING LOT EVALUATION CONFIRMED ALL DEVICES MET SPECIFICATIONS PRIOR TO RELEASE. THE DEVICE WAS NOT RETURNED AS THE DEVICE REMAINS IMPLANTED; THEREFORE, NO EVALUATION WAS COMPLETED. 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. DEVICE ITERATION IS AFX WITH DURAPLY. CORRECTIONS: G1,2: CONTACT OFFICE- NAME HAS BEEN UPDATED H6: RESULT CODE: REMOVE CODE 3233. H6: CONCLUSION CODE: REMOVE CODE 11.

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE 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 AND TWO (2) INFRARENAL STENT GRAFT EXTENSIONS TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY 3.5 YEARS POST INITIAL PROCEDURE, A TYPE 2 ENDOLEAK (NON - DEVICE RELATED FAILURE) OF INFERIOR MESENTERIC ARTERY (IMA) WAS REPORTED AND THE PHYSICIAN ELECTED TO COIL THE IMA. NOW, APPROXIMATELY FOUR (4) YEARS POST INITIAL PROCEDURE, A TYPE 1B ENDOLEAK ON THE RIGHT SIDE WAS IDENTIFIED DURING A ROUTINE FOLLOW UP. AN INTERVENTION WAS COMPLETED. THE PHYSICIAN ELECTED TO RELINE THE ORIGINAL IMPLANTED DEVICES WITH AN AFX2 BIFURCATED STENT GRAFT, A VELA SUPRARENAL STENT GRAFT EXTENSION AND TWO (2) OVATION IX EXTENDER TO RESOLVE THIS REPORTED EVENT. THE PATIENT WAS REPORTED TO BE DISCHARGED POST INTERVENTION WITH NO ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    598071 AFX BIFURCATED STENT GRAFT MIH ENDOLOGIX, INC. BA28-90/I20-30 1251901-007 00818009012630

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention COILS (NON ENDOLOGIX)| VELA INFRARENAL, LOT 1247645-014| VELA INFRARENAL, LOT 1252143-010