BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALTO

    MDR report key: 18754732 · Received February 21, 2024

    Report

    Report Number
    3008011247-2024-00018
    Event Type
    Injury
    Date Received
    February 21, 2024
    Date of Event
    February 1, 2024
    Report Date
    February 1, 2024
    Manufacturer
    ENDOLOGIX SANTA ROSA
    Product Code
    MIH
    PMA / PMN Number
    P120006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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: DEVICE REMAINS IMPLANTED.

    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'S 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 THAT THE ALTO, TYPE IA ENDOLEAK COMPLAINT IS CONFIRMED. THIS IS CONSISTENT WITH THE REPORTED ADVERSE EVENT/INCIDENT. THE COMPLAINT IS MOST LIKELY ANATOMY-RELATED. PROCEDURE-RELATED HARMS OF THIS COMPLAINT COULD NOT BE DETERMINED WITH THE MEDICAL RECORDS AVAILABLE FOR REVIEW. 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: G3: AWARENESS DATE H6: INVESTIGATION FINDING CODES - REMOVE CODE 3233 H6: INVESTIGATION CONCLUSION CODES - REMOVE CODE 11.

    Description of Event or Problem · 0

    THE PATIENT WAS IMPLANTED WITH THE ALTO STENT GRAFT SYSTEM TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA) ON (B)(6) 2024. THIS INITIAL PROCEDURE IS OUTSIDE THE INDICATIONS OF USE (OFF-LABEL) DUE TO THE USE OF ADJUNCTIVE DEVICES NOT COMPATIBLE WITH THE ALTO STENT GRAFT SYSTEM PER THE IFU. IT WAS REPORTED THAT THE PROCEDURE WAS CHALLENGING DUE TO ANGULATION AND A SHORT NECK. DESPITE THESE OBSTACLES, THE PHYSICIAN MANAGED TO IMPLANT THE ALTO STENT GRAFT AND PERFORM BALLOON DILATION 16 MINUTES AFTER POLYMER MIXING. BOTH LIMBS WERE POSITIONED WITHOUT DIFFICULTY. FOLLOWING THE IMPLANTATION, THERE WAS A NOTABLE AGGRESSIVE TYPE IA ENDOLEAK. TO ADDRESS THIS, A (NON-ENDOLOGIX) PALMAZ P4010 WITH A NEW CODA BALLOON WAS INTRODUCED, BUT THE IA ENDOLEAK PERSISTED AT A REDUCED RATE. ADDITIONAL ATTEMPTS WITH A Q50 BALLOON AND ZMED 25X40 BALLOON WERE UNSUCCESSFUL IN COMPLETELY HALTING THE IA ENDOLEAK. AS A FINAL MEASURE, A (NON-ENDOLOGIX) GORE EXCLUDER EXTENSION WAS DEPLOYED, RESULTING IN A SIGNIFICANT REDUCTION IN THE IA ENDOLEAK. THE PATIENT WILL BE MONITORED CLOSELY BY THE MEDICAL TEAM, WITH PLANS FOR REASSESSMENT AT THE 30-DAY FOLLOW-UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    62492 ALTO MAIN BODY MIH ENDOLOGIX SANTA ROSA TV-AB2680-N FS101823-29

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Female Other (NE) CORDIS P4010 PALMAZ XL TRANSHEPATIC BILIARY.| (NON-ENDOLOGIX) GORE EXCLUDER EXTENSION.| OVATION IX ILIAC LIMB FS050923-11.| OVATION IX ILIAC LIMB FS080123-15.| OVATION PRIME FILL POLYMER FF041823-01.