BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OVATION IX

    MDR report key: 13529897 · Received February 14, 2022

    Report

    Report Number
    3008011247-2022-00010
    Event Type
    Injury
    Date Received
    February 14, 2022
    Date of Event
    January 24, 2022
    Report Date
    January 24, 2022
    Manufacturer
    ENDOLOGIX SANTA ROSA
    Product Code
    MIH
    UDI-DI
    M701TVAB3480J1
    PMA / PMN Number
    P120006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Additional Manufacturer Narrative · 0

    THE REPORTED ADVERSE EVENT/INCIDENT WAS INVESTIGATED IN ALIGNMENT WITH ENDOLOGIX OPERATING PROCEDURES AND WORK INSTRUCTIONS. WHERE POSSIBLE, IT IS ENDOLOGIX PRACTICE TO MAKE AT LEAST THREE GOOD FAITH EFFORTS TO RETRIEVE A REPORTED ADVERSE EVENT/INCIDENT RELATED DEVICE AS WELL AS MEDICAL RECORDS AND MEDICAL IMAGING. AN EVALUATION OF THE MANUFACTURING RECORD WAS COMPLETED. A REVIEW OF THE PART NUMBER/LOT NUMBER COMBINATION NEEDED FOR DEVICE IDENTIFICATION SHOWS THE DEVICE TO HAVE BEEN PROPERLY MANUFACTURED AND RELEASED IN ACCORDANCE WITH THE DEVICE MASTER RECORD. THE REVIEW CONFIRMS THERE WERE NO MANUFACTURING OR PROCESSING NON-CONFORMITIES IDENTIFIED THAT WOULD CONTRIBUTE TO THE REPORTED ADVERSE EVENT/INCIDENT. AN EVALUATION OF THE DEVICE COULD NOT BE COMPLETED. THE DEVICE WAS NOT RETURNED TO ENDOLOGIX FOR EVALUATION BECAUSE IT REMAINS IMPLANTED. A CLINICAL EVALUATION OF THE ADVERSE EVENT/INCIDENT WAS COMPLETED. AN EXAMINATION OF MEDICAL RECORDS AND/OR MEDICAL IMAGING RECEIVED BY ENDOLOGIX SHOWS THAT THE TYPE 1A ENDOLEAK, SAC GROWTH OF 35MM AND SECONDARY ENDOVASCULAR PROCEDURE ARE CONFIRMED. THE MIGRATION IS UNCONFIRMED. THIS IS MODERATELY CONSISTENT WITH THE REPORTED ADVERSE EVENT/INCIDENT. THE MOST LIKELY CAUSATION FOR THIS EVENT IS USER RELATED. THE RADIOPAQUE MARKERS WERE PLACED LOW (9.4MM BELOW THE RIGHT RENAL ARTERY). IT IS UNCLEAR IF THERE WAS MIGRATION OR IF THE AORTIC BODY HAD SUBOPTIMAL PLACEMENT AT THE INDEX PROCEDURE. THE PROCEDURE RELATED HARM IDENTIFIED WAS A POST OPERATIVE STROKE AND CEREBRAL ISCHEMIA. THE PATIENT HAD A CORONARY STENT PLACED 1 WEEK PRIOR TO THE REPAIR PROCEDURE (CAUTIONARY PRODUCT USE) AND HAD A HISTORY OF CORONARY ARTERY DISEASE (CAD). THE MRI STATED THE BRAIN EMBOLISM WAS MOST LIKELY A CARDIOMEGALY SOURCE. THE FINAL PATIENT STATUS WAS DISCHARGED HOME IN STABLE AND IMPROVING CONDITION ON THE FIFTH POST OPERATIVE DAY. NO ADDITIONAL INVESTIGATION OF THIS REPORTED ADVERSE EVENT/INCIDENT IS PLANNED. HOWEVER, SHOULD ADDITIONAL INFORMATION RELEVANT TO THE INVESTIGATION OUTCOME BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. ENDOLOGIX WILL CONTINUE TO MONITOR THIS AND SIMILAR ADVERSE EVENTS/INCIDENTS.

    Description of Event or Problem · 0

    THE PATIENT WAS INITIALLY IMPLANTED WITH THE OVATION IX STENT GRAFT SYSTEM TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY FOUR (4) YEARS POST INITIAL PROCEDURE, DURING A ROUTINE FOLLOW UP, THERE WAS STENT GRAFT MIGRATION, A TYPE 1A ENDOLEAK AND ANEURYSM ENLARGEMENT NOTED. THE PHYSICIAN ELECTED TO RELINE THE ORIGINAL IMPLANTED DEVICES WITH AN ALTO STENT GRAFT SYSTEM TO RESOLVE THIS EVENT. THE PATIENT WAS REPORTED AS DOING WELL POST SECONDARY PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    559192 OVATION IX MAIN BODY MIH ENDOLOGIX SANTA ROSA TV-AB3480-J FS021717-17 M701TVAB3480J1

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male Required Intervention OVATION IX ILIAC LIMB, LOT # FS061217-06| OVATION IX ILIAC LIMB, LOT # FS100616-19| OVATION PRIME FILL POLYMER, LOT # FF070617-01