BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALTO

    MDR report key: 20296432 · Received September 24, 2024

    Report

    Report Number
    3008011247-2024-00103
    Event Type
    Malfunction
    Date Received
    September 24, 2024
    Date of Event
    September 4, 2024
    Report Date
    September 4, 2024
    Manufacturer
    ENDOLOGIX SANTA ROSA
    Product Code
    MIH
    UDI-DI
    00850007370893
    PMA / PMN Number
    P120006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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 ALTO, INTRAOPERATIVE FILLING PROBLEM (NO FILL OF THE CONTRALATERAL LIMB AND PARTIAL FILL OF SEALING AND SUPPORT RINGS) IS UNCONFIRMED. THIS IS NOT CONSISTENT WITH THE REPORTED ADVERSE EVENT/INCIDENT. NO CONTRIBUTING FACTORS WERE IDENTIFIED. PROCEDURE-RELATED HARMS, DEVICE, USER, PROCEDURE, OR ANATOMY-RELATEDNESS OF THIS COMPLAINT COULD NOT BE DETERMINED WITH THE MEDICAL RECORDS AVAILABLE FOR REVIEW. THE FINAL PATIENT STATUS WAS REPORTED AS BEING 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. CORRECTIONS: H6 INVESTIGATION FINDING CODES ¿ REMOVE CODE 3233 H6 INVESTIGATION CONCLUSION CODES ¿ REMOVE CODE 11.

    Additional Manufacturer Narrative · 0

    THE DEVICES INVOLVED IN THIS EVENT WILL NOT BE RETURNED FOR EVALUATION AND REMAIN IMPLANTED IN THE PATIENT. 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, FOLLOW-UP REPORT WILL BE SUBMITTED. DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 0

    THE PATIENT WAS BEING TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) ON (B)(6) 2024, WITH THE IMPLANTATION OF AN ALTO STENT GRAFT SYSTEM. DURING THE PROCEDURE, IT WAS REPORTED THAT THE GRAFT WAS INSERTED VIA THE LEFT GROIN, POSITIONED ANTERIORLY, AND CONNECTED TO THE POLYMER. THE PHYSICIAN REPOSITIONED THE STIFF WIRE TO HELP THE GRAFT SETTLE MORE NATURALLY, BUT UNDER FLUOROSCOPY, ONLY THE IPSILATERAL GATE RINGS FILLED, WHILE THE CONTRALATERAL GATE RING, SEALING RING, AND SUPPORT RING DID NOT. ATTEMPTS TO ADJUST THE GRAFT WITH SLIGHT PRESSURE RESULTED IN MINIMAL FILLING OF THE SEALING AND SUPPORT RINGS, BUT THE CONTRALATERAL GATE RINGS REMAINED UNFILLED. AFTER THE 14-MINUTE POLYMER SET TIMER, THE SEALING RING WAS BALLOONED, AND BOTH LIMBS WERE PLACED, FOLLOWED BY BALLOONING WITH 10X40 BALLOONS. A (NON-ENDOLOGIX) 3110 PALMAZ STENT WAS DEPLOYED TO ACHIEVE A SEAL. THE PROCEDURE WAS COMPLETED WITHOUT ANY ENDOLEAKS, AND THE PATIENT REMAINED STABLE, LATER BEING TRANSFERRED TO THE ICU FOR MONITORING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2017277 ALTO MAIN BODY MIH ENDOLOGIX SANTA ROSA TV-AB2680-N FS022724-13 00850007370893

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Male Other (NON-ENDOLOGIX)CORDIS 3110 PALMAZ STENT| OVATION IX ILIAC LIMB LOT# FS011124-45| OVATION IX ILIAC LIMB LOT# FS092022-34| OVATION PRIME FILL POLYMER LOT# FF083023-02