BEUDAMED
    FDA Adverse Event Death Summary report: N

    AFX2

    MDR report key: 9914406 · Received April 1, 2020

    Report

    Report Number
    2031527-2020-00123
    Event Type
    Death
    Date Received
    April 1, 2020
    Date of Event
    February 29, 2020
    Report Date
    March 4, 2020
    Manufacturer
    ENDOLOGIX
    Product Code
    MIH
    UDI-DI
    00818009015068
    PMA / PMN Number
    P040002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    AN EVALUATION OF THE REPORTED EVENT COULD NOT BE COMPLETED DUE TO A LACK OF RECEIPT OF RELEVANT MEDICAL RECORDS AND/OR IMAGING. SEVERAL ATTEMPTS WERE MADE TO OBTAIN MEDICAL RECORDS AND IMAGES BUT THE REQUEST FOR MEDICAL RECORDS WAS DENIED AND NO RESPONSE WAS RECEIVED FOR THE REQUEST OF MEDICAL IMAGES. AS SUCH, EVENT DETERMINATION, OFF LABEL CONDITIONS, RELATED PATIENT HARMS AND PATIENT DISPOSITION COULD NOT BE ASSESSED. 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 AFX2. CORRECTIONS: RESULT CODE ¿ REMOVE 3233.

    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 AFX2. DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 1

    THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT GRAFT TO TREAT AN OCCLUSIVE DISEASE IN THE DISTAL AORTA AND THROMBUS LINING THE AORTA FROM THE BIFURCATION TO THE MID AORTA. THIS CASE IS OUTSIDE THE INDICATIONS OF USE (OFF -LABEL) DUE THE DEVICE BEING USED TO TREATMENT NOT APPROVED PER THE IFU. IT WAS ALSO REPORTED THAT PHYSICIAN HAD TO PERFORM A CUT DOWN DURING THE INITIAL PROCEDURE DUE TO EMBOLIZATION. APPROXIMATELY 16 DAYS POST INITIAL PROCEDURE, THE PATIENT WAS PRESENT IN THE EMERGENCY ROOM (ER) DUE TO AN OCCLUDED AORTA. IT WAS REPORTED THAT THE PATIENT WAS NOT TAKING THE ANTIPLATELET THERAPY AND THROMBOSED THE GRAFT. THE PHYSICIAN ELECTED TO TREAT THE PATIENT WITH A MANUAL THROMBECTOMY AND IMPLANT TWO (2) NON- ENDOLOGIX (GORE) LIMB EXTENSIONS TO RE-LINE THE AORTA. THE RE-INTERVENTION WAS SUCCESSFUL HOWEVER THE PATIENT WAS STILL IN POOR HEALTH. THE PATIENT EXPIRED ON THE FOLLOWING DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    372685 AFX2 BIFURCATED STENT GRAFT MIH ENDOLOGIX BEA22-60/I13-40 1723092-006 00818009015068

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Death| R