BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALTO

    MDR report key: 16414918 · Received February 21, 2023

    Report

    Report Number
    3008011247-2023-00025
    Event Type
    Malfunction
    Date Received
    February 21, 2023
    Date of Event
    February 2, 2023
    Report Date
    February 2, 2023
    Manufacturer
    ENDOLOGIX SANTA ROSA
    Product Code
    MIH
    UDI-DI
    00850007370909
    PMA / PMN Number
    P120006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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 NO POLYMER FILL OF THE CONTRALATERAL LIMB AND TYPE 1A ENDOLEAK (REPORTED AS RESOLVED) ARE UNCONFIRMED. THIS IS NOT CONSISTENT WITH THE REPORTED ADVERSE EVENT/INCIDENT. IT WAS REPORTED THAT THE AORTIC NECK WAS HIGHLY ANGULATED WITH A JUXTARENAL ANGLE OF 59.9° AND INFRARENAL ANGLE OF 78.6°. THIS COULD HAVE CONTRIBUTED TO THE REPORTED EVENTS. THE COMPLAINT COULD NOT BE CONFIRMED HENCE CAUSATION CANNOT BE CONCLUSIVELY DETERMINED. DEVICE, USER, PROCEDURE OR ANATOMY RELATEDNESS OF THIS COMPLAINT COULD NOT BE DETERMINED. PROCEDURE RELATED HARMS FOR THIS COMPLAINT COULD NOT BE DETERMINED. THE FINAL PATIENT STATUS WAS REPORTED AS DOING FINE. 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.

    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. DEVICE REMAIN IMPLANTED.

    Description of Event or Problem · 0

    THE PATIENT WAS IMPLANTED WITH THE ALTO STENT GRAFT SYSTEM TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). IT WAS NOTED THAT THE AORTIC NECK WAS ANGULATED AND CONTAINED CALCIUM. DURING THIS INITIAL PROCEDURE, THE CONTRALATERAL LIMB DID NOT FILL WITH POLYMER AND THERE AS A TYPE 1 ENDOLEAK. A PALMAZ (NON-ENDOLOGIX) STENT WAS PLACED TO RESOLVE THE ENDOLEAK. THE FINAL PATIENT STATUS WAS REPORTED AS DOING FINE. THE DELIVERY SYSTEM IS NOT AVAILABLE FOR RETURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1407291 ALTO MAIN BODY MIH ENDOLOGIX SANTA ROSA TV-AB2980-N FS060622-53 00850007370909

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Female Other OVATION IX ILIAC LIMB, LOT # FS070722-60| OVATION IX ILIAC LIMB, LOT # FS080322-29| OVATION PRIME FILL POLYMER, LOT # FF070722-01