BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALTO

    MDR report key: 19945462 · Received August 8, 2024

    Report

    Report Number
    3008011247-2024-00089
    Event Type
    Malfunction
    Date Received
    August 8, 2024
    Date of Event
    July 26, 2024
    Report Date
    July 26, 2024
    Manufacturer
    ENDOLOGIX SANTA ROSA
    Product Code
    MIH
    UDI-DI
    00850007370961
    PMA / PMN Number
    P120006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICES INVOLVED IN THIS EVENT WILL NOT BE RETURNED FOR EVALUATION AND REMAIN IMPLANTED IN THE PATIENT. PATIENT MEDICAL RECORDS AND IMAGING STUDIES WILL BE REQUESTED FOR FURTHER EVALUATION BY A CLINICAL SPECIALIST. IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED, 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. THERE ARE NO OTHER EQUIVALENT ADVERSE EVENTS/INCIDENTS FOR THIS LOT NUMBER EXISTING WITHIN THE ENDOLOGIX COMPLAINT HANDLING SYSTEM. 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 COULD NOT BE COMPLETED. NO MEDICAL RECORDS NOR MEDICAL IMAGING RELEVANT TO THE REPORTED ADVERSE EVENT/INCIDENT WAS RECEIVED BY ENDOLOGIX. THE USER FACILITY WAS UNABLE TO PROVIDE THIS INFORMATION. DUE TO THE ABSENCE OF MEDICAL RECORDS AND MEDICAL IMAGING; DEVICE, USE, PROCEDURE, AND/OR ANATOMY RELATEDNESS TO THIS ADVERSE EVENT/INCIDENT COULD NOT BE EVALUATED. AS SUCH, EVENT DETERMINATION, OFF LABEL CONDITIONS, RELATED PATIENT HARMS AND PATIENT DISPOSITION COULD NOT BE INDEPENDENTLY ASSESSED. THE FINAL PATIENT STATUS REMAINS UNKNOWN. THE FINAL PATIENT STATUS WAS NOT MADE AVAILABLE TO ENDOLOGIX. 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. CORRECTIONS: H6 INVESTIGATION FINDING CODES ¿ REMOVE CODE 3233. H6 INVESTIGATION CONCLUSION CODES ¿ REMOVE CODE 11.

    Description of Event or Problem · 0

    THE PATIENT WAS BEING TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) ON (B)(6) 2024 WITH THE IMPLANT OF AN ALTO STENT GRAFT SYSTEM. IT WAS REPORTED THAT THERE WAS ONLY PARTIAL FILLING OF THE PROXIMAL RING AND NO FILL OF THE CONTRALATERAL LIMB. THE FINAL PATIENT STATUS WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1702887 ALTO MAIN BODY MIH ENDOLOGIX SANTA ROSA TV-AB3480-L FS050724-26 00850007370961

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other OVATION IX ILIAC LIMB (LN FS092923-23)| OVATION IX ILIAC LIMB (LN FS110123-49)| OVATION PRIME FILL POLYMER (LN FF071023-01)