BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALTO

    MDR report key: 16497664 · Received March 7, 2023

    Report

    Report Number
    3008011247-2023-00027
    Event Type
    Malfunction
    Date Received
    March 7, 2023
    Date of Event
    February 20, 2023
    Report Date
    February 20, 2023
    Manufacturer
    ENDOLOGIX SANTA ROSA
    Product Code
    MIH
    UDI-DI
    00850007370954
    PMA / PMN Number
    P120006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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 THE REPORTED ALTO, INTRAOPERATIVE SLOW FILL OF THE CONTRALATERAL LIMB, TWISTING OF THE AORTIC BODY AND BUCKLING ARE CONFIRMED. THIS IS 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. THE FINAL PATIENT STATUS WAS REPORTED AS STABLE. 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.

    Additional Manufacturer Narrative · 0

    THE DEVICES INVOLVED IN THIS EVENT HAVE NOT 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. DEVICES NOT RETURNED.

    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, IT WAS OBSERVED THAT THE CONTRALATERAL LIMB TO THE MAIN BODY FILLED SLOWER THAN EXPECTED AS IT TOOK OVER ONE MINUTE FOR THE POLYMER TO APPEAR. ONCE THE CONTRALATERAL LIMB FILLED, THE LIMBS TO THE MAIN BODY SHOWED AS TWISTED, WHICH RESULTED IN THE MAIN BODY BECOMING CRIMPED. THE PHYSICIAN ELECTED TO EXTEND ON THE LEFT SIDE WITH A SECOND ILIAC LIMB. FINAL IMAGING SHOWED THE ANEURYSM WAS EXCLUDED WITHOUT ANY RESIDUAL ENDOLEAK. THE PATIENT IS REPORTEDLY IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    659159 ALTO MAIN BODY MIH ENDOLOGIX SANTA ROSA TV-AB2980-L FS061522-37 00850007370954

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Other OVATION IX ILIAC LIMB, LN FS071422-46| OVATION IX ILIAC LIMB, LN FS072122-48| OVATION IX ILIAC LIMB, LN FS072122-65| OVATION IX ILIAC LIMB, LN FS075122-13| OVATION PRIME FILL POLYMER, LN FF101221-01