BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALTO

    MDR report key: 16984772 · Received May 23, 2023

    Report

    Report Number
    3008011247-2023-00064
    Event Type
    Malfunction
    Date Received
    May 23, 2023
    Date of Event
    May 1, 2023
    Report Date
    May 1, 2023
    Manufacturer
    ENDOLOGIX SANTA ROSA
    Product Code
    MIH
    UDI-DI
    00850007370893
    PMA / PMN Number
    P120006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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. A CLINICAL EVALUATION OF THE ADVERSE EVENT/INCIDENT WAS COMPLETED. AN EXAMINATION OF MEDICAL RECORDS AND/OR MEDICAL IMAGING RECEIVED BY ENDOLOGIX SHOWS THE REPORTED ALTO DELIVERY SYSTEM, INTRAOPERATIVE NO POLYMER FILL IS UNCONFIRMED. THE REPORTED SLOW POLYMER FILL IS CONFIRMED. THIS IS MODERATELY CONSISTENT WITH THE REPORTED ADVERSE EVENT/INCIDENT. PROCEDURE-RELATED HARMS, DEVICE, USER, PROCEDURE, OR ANATOMY RELATEDNESS OF THIS EVENT COULD NOT BE DETERMINED WITH THE MEDICAL RECORDS AVAILABLE FOR REVIEW. IT WAS ALSO NOTED THAT THE INITIAL IMPLANT PROCEDURE WAS AN OFF-LABEL CASE DUE TO THE ABSENCE OF AN ABDOMINAL AORTIC ANEURYSM SAC AND THE LEFT COMMON ILIAC MAXIMUM DIAMETER MEASURING 33.6MM (DEVICE IFU REQUIREMENT IS 8-25MM). THE FINAL PATIENT STATUS WAS NOT REPORTED. 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. H6 INVESTIGATION FINDING CODES; REMOVE 3233. H6 INVESTIGATION CONCLUSION CODES; REMOVE 11.

    Additional Manufacturer Narrative · 0

    THE DELIVERY SYSTEM DEVICES INVOLVED IN THIS EVENT WILL NOT BE RETURNED FOR EVALUATION AND WERE DISCARDED. 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, A FOLLOW-UP REPORT WILL BE SUBMITTED. DELIVERY SYSTEM UNAVAILABLE.

    Description of Event or Problem · 0

    THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH IMPLANT OF THE ALTO ABDOMINAL AORTIC ANEURYSM STENT SYSTEM. DURING THE INITIAL IMPLANT PROCEDURE, THE PHYSICIAN EXPERIENCED DIFFICULTY DISPENSING THE POLYMER (CHARACTERIZED AS A SLOW FILL). TROUBLESHOOTING INCLUDED INFLATING THE INTEGRATED BALLOON (5CC) AT 3 MINUTES AND 30 SECONDS AFTER ATTACHING THE AUTOINJECTOR, DETACHING AND REATTACHING THE AUTOINJECTOR AT 4 MINUTES AND 30 SECONDS, PULLING DOWN THE SECOND RING OF THE CONTRALATERAL LIMB WITH A 0.014 WIRE, AND SWITCHING TO A V18 WIRE. ULTIMATELY, THE CONTRALATERAL LIMB WAS SHORT-FILLED. THE PROCEDURE WAS CONCLUDED AND NO INJURY TO PATIENT WAS OBSERVED. THE DELIVERY SYSTEM IS UNAVAILABLE FOR RETURN/EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1462880 ALTO MAIN BODY DELIVERY SYSTEM MIH ENDOLOGIX SANTA ROSA TV-AB2680-N FS030223-16 00850007370893

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Male Other OVATION IX ILIAC LIMB, LN FS022223-16.| OVATION IX ILIAC LIMB, LN FS082720-19.| OVATION IX ILIAC LIMB, LN FS111622-33.| OVATION PRIME FILL POLYMER, LN F010323-01.