BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALTO

    MDR report key: 16932204 · Received May 15, 2023

    Report

    Report Number
    3008011247-2023-00055
    Event Type
    Malfunction
    Date Received
    May 15, 2023
    Date of Event
    April 24, 2023
    Report Date
    April 24, 2023
    Manufacturer
    ENDOLOGIX SANTA ROSA
    Product Code
    MIH
    UDI-DI
    00850007370916
    PMA / PMN Number
    P120006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 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 THAT THE NO POLYMER FILL IN THE CONTRALATERAL LIMB AND TYPE 1A ENDOLEAK (RESOLVED) ARE CONFIRMED. THIS IS CONSISTENT WITH THE REPORTED ADVERSE EVENT/INCIDENT. DEVICE, USER, PROCEDURE OR ANATOMY RELATEDNESS OF THIS COMPLAINT COULD NOT BE DETERMINED. NO PROCEDURE RELATED HARMS FOR THIS COMPLAINT WERE IDENTIFIED. THE FINAL PATIENT STATUS WAS REPORTED TO BE DISCHARGED TO A REHABILITATION FACILITY ON POSTOPERATIVE DAY 10, HOSPITAL DAY 17. 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 HAS BEEN 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 AS IT 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 : STENT GRAFT REMAINS IMPLANTED.

    Description of Event or Problem · 0

    THE PATIENT WAS IMPLANTED WITH THE ALTO STENT GRAFT SYSTEM TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). DURING THIS INITIAL PROCEDURE, THE MAIN BODY DEPLOYMENT POLYMER FILL WAS VERY SLOW, AND AFTER SEVERAL MINUTES THE IPSILATERAL LIMB AND MAIN BODY WERE FILLED; HOWEVER, THE CONTRALATERAL LIMB DID NOT FILL. IT APPEARED TO BE TWISTED AND THE POLYMER STOPPED AT THE LONGITUDINAL FILL CHANNEL ABOVE THE CONTRALATERAL LIMB. WITH DIFFICULTY THE PHYSICIAN WAS ABLE TO GO UP AND OVER USING THE CROSSOVER LUMEN AND SNARED AN 0.014" WIRE. THE PHYSICIAN WAS THEN ABLE TO GET ACCESS WITH A 0.035" WIRE AND DEPLOY THE CONTRALATERAL AND IPSILATERAL LIMBS. THE MAIN BODY RINGS WERE BALLOONED AT 15 MINUTES AND THEN THE GATES AND ILIAC LIMBS AFTER THEY WERE DEPLOYED. A TYPE 1A ENDOLEAK WAS NOTED AND A PALMAZ P40-10 (NON-ENDOLOGIX) STENT WAS DEPLOYED. A COMPLETION ANGIOGRAM SHOWED NO ENDOLEAK AT THE END OF THE PROCEDURE AND BLOOD FLOW THROUGH THE GRAFT LOOKED GOOD. THE DELIVERY SYSTEM WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1651365 ALTO MAIN BODY MIH ENDOLOGIX SANTA ROSA TV-AB3480-N FS092922-11 00850007370916

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Male Other OVATION IX ILIAC LIMB, LOT # FS050222-16| OVATION IX ILIAC LIMB, LOT # FS100422-13| OVATION PRIME FILL POLYMER, LOT # FF033022-02| PALMAZ P40-10 (NON-ENDOLOGIX) STENT