BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALTO

    MDR report key: 19491483 · Received June 7, 2024

    Report

    Report Number
    3008011247-2024-00067
    Event Type
    Malfunction
    Date Received
    June 7, 2024
    Date of Event
    May 14, 2024
    Report Date
    May 14, 2024
    Manufacturer
    ENDOLOGIX SANTA ROSA
    Product Code
    MIH
    UDI-DI
    00850007370909
    PMA / PMN Number
    P120006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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. 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 THE INTRAOPERATIVE FILL PROBLEM (CONTRALATERAL) IS CONFIRMED. THIS IS CONSISTENT WITH THE REPORTED ADVERSE EVENT/INCIDENT. THE SHARP 70-DEGREE INFRARENAL ANGULATION IN COMBINATION WITH THE LARGE THROMBUS BURDEN AND THICKENED CALCIFICATIONS LIKELY CONTRIBUTED TO THE COMPLAINT. THE COMPLAINT IS MOST LIKELY ANATOMY-RELATED. PROCEDURE-RELATED HARMS OF THIS COMPLAINT COULD NOT BE DETERMINED WITH THE MEDICAL RECORDS AVAILABLE FOR REVIEW. THE FINAL PATIENT STATUS WAS REPORTED TO BE DOING WELL. 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: G3: AWARENESS DATE ¿ UPDATED. 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 AND THE STENT GRAFT 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. H3 OTHER TEXT : DEVICE REMAINS IMPLANTED

    Description of Event or Problem · 0

    THE PATIENT WAS BEING TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE IMPLANTATION OF THE ALTO ABDOMINAL STENT GRAFT SYSTEM ON (B)(6) 2024. THE ALTO MAIN BODY WAS DEPLOYED, AND DURING POLYMER FILL, THE CONTRALATERAL LIMB DID NOT FILL. THE PATIENT REQUIRED BILATERAL SURGICAL INCISIONS ON THE FEMORAL ARTERIES DUE TO FAILURES WITH THE PROGLIDE. THE FINAL PATIENT STATUS WAS REPORTED AS ALIVE AND WELL, WITH NO REPORTED ENDOLEAKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    998809 ALTO MAIN BODY MIH ENDOLOGIX SANTA ROSA TV-AB2980-N FS010524-50 00850007370909

    Patients

    Seq Age Sex Outcome Treatment
    1 96 YR Male Other OVATION IX ILIAC LIMB FS011723-43.| OVATION IX ILIAC LIMB FS091223-43.| OVATION PRIME FILL POLYMER FF082923-03.