BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALTO

    MDR report key: 12140941 · Received July 9, 2021

    Report

    Report Number
    3008011247-2021-00072
    Event Type
    Injury
    Date Received
    July 9, 2021
    Date of Event
    June 18, 2021
    Report Date
    June 18, 2021
    Manufacturer
    ENDOLOGIX SANTA ROSA
    Product Code
    MIH
    PMA / PMN Number
    P120006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    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 TYPE 1A ENDOLEAK IS CONFIRMED. THIS IS CONSISTENT WITH THE REPORTED ADVERSE EVENT/INCIDENT. 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 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: G4 AWARENESS DATE . H6 EVALUATION RESULT CODES; REMOVE 3233. H6 EVALUATION CONCLUSION CODES; REMOVE 11.

    Additional Manufacturer Narrative · 1

    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, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE ALTO ABDOMINAL AORTIC ANEURYSM STENT SYSTEM. DURING THE INITIAL IMPLANT PROCEDURE, A TYPE IA ENDOLEAK WAS OBSERVED. THE PHYSICIAN ELECTED TO CONCLUDE THE PROCEDURE AND WILL FOLLOW-UP WITH THE PATIENT IN ONE MONTH. THE PATIENT IS REPORTEDLY STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1040698 ALTO MAIN BODY MIH ENDOLOGIX SANTA ROSA TV-AB2980-L FS020921-23

    Patients

    Seq Age Sex Outcome Treatment
    1 Other FILL POLYMER, SN (B)(6)| OVATION IX ILIAC LIMB, SN (B)(6)| OVATION IX ILIAC LIMB, SN (B)(6)| FILL POLYMER, SN (B)(4)| OVATION IX ILIAC LIMB, SN (B)(4)| OVATION IX ILIAC LIMB, SN (B)(4)