BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALTO

    MDR report key: 16260451 · Received January 27, 2023

    Report

    Report Number
    3008011247-2023-00011
    Event Type
    Malfunction
    Date Received
    January 27, 2023
    Date of Event
    January 6, 2023
    Report Date
    January 6, 2023
    Manufacturer
    ENDOLOGIX SANTA ROSA
    Product Code
    MIH
    UDI-DI
    00850007370916
    PMA / PMN Number
    P120006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 INITIALLY REPORTED AS AVAILABLE FOR RETURN; HOWEVER, IT WAS LATER DISCOVERED THAT DEVICE WAS DISCARDED BY THE HOSPITAL, AND THEREFORE IT 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 INTRAOPERATIVE BROKEN COMPONENT OF THE ALTO DELIVERY SYSTEM AND NO POLYMER FILL OF THE CONTRALATERAL LIMB ARE CONFIRMED. THIS IS CONSISTENT WITH THE REPORTED ADVERSE EVENT/INCIDENT. DEVICE, USER, PROCEDURE, OR ANATOMY RELATEDNESS OF THIS EVENT COULD NOT BE DETERMINED WITH THE MEDICAL RECORDS AVAILABLE FOR REVIEW. NO-PROCEDURE RELATED HARMS FOR THIS EVENT WERE IDENTIFIED. THE FINAL PATIENT STATUS WAS REPORTED AS DISCHARGED HOME ON POSTOPERATIVE DAY TWO. 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: D9 DEVICE AVAILABLE FOR EVAL? G3 AWARENESS DATE. H3 REASON DEVICE NOT EVAL. H6 INVESTIGATION FINDING CODES; REMOVE 3233. H6 INVESTIGATION CONCLUSION CODES; REMOVE 11 H3 OTHER TEXT : DEVICE DISCARDED BY HOSPITAL.

    Additional Manufacturer Narrative · 0

    THE DEVICES INVOLVED IN THIS EVENT WILL BE RETURNED FOR EVALUATION. 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.

    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 CONTRALATERAL LIMB OF THE MAIN BODY DID NOT FILL WITH POLYMER. IN ADDITION, THE BALLOON PORT WAS CRACKED, WHICH RESULTED IN PHYSICIAN BEING UNABLE TO OPEN THE MID-CROWN TO VIEW PARALLAX AND THE INABILITY TO BALLOON THE MAIN BODY. NO IMPACT WAS REPORTED TO PATIENT. THE DEVICE IS AVAILABLE FOR RETURN/EVALUATION. NOTE: BASED ON A SIMILAR EVENT(S) WITH THE SAME FAILURE MODE OCCURRING WITHIN THE LAST TWO (2) YEARS THAT DID CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY OF THE PATIENT AND/OR USER, THE DEVICE TO THIS EVENT COULD HAVE CONTRIBUTED TO A DEATH OR SERIOUS INJURY, AND THEREFORE THIS EVENT IS REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400326 ALTO MAIN BODY DELIVERY SYSTEM MIH ENDOLOGIX SANTA ROSA TV-AB3480-N FS040822-13 00850007370916

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Unknown Other OVATION IX ILIAC LIMB, LN FS071822-32| OVATION IX ILIAC LIMB, LN FS081922-70| OVATION PRIME FILL POLYMER, LN FF062322-01