BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALTO

    MDR report key: 19707174 · Received July 9, 2024

    Report

    Report Number
    3008011247-2024-00080
    Event Type
    Injury
    Date Received
    July 9, 2024
    Date of Event
    June 28, 2024
    Report Date
    June 28, 2024
    Manufacturer
    ENDOLOGIX SANTA ROSA
    Product Code
    MIH
    UDI-DI
    M701TVAB3480N1
    PMA / PMN Number
    P120006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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 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. 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 IIIB ENDOLEAK IS CONFIRMED. THIS IS CONSISTENT WITH THE REPORTED ADVERSE EVENT/INCIDENT. THE CLINICAL EVALUATION ALSO SHOWS REASONABLE EVIDENCE TO SUGGEST ANEURYSM SAC GROWTH OF 22MM OCCURRED THAT WAS NOT INCLUDED IN THE EVENT AS REPORTED. THE MOST LIKELY CAUSATION FOR THE EVENT WAS USER/PROCEDURE RELATED (PREVIOUS LUMBAR COILING). IT WAS REPORTED THERE WERE TWO TREATMENTS FOR TYPE II ENDOLEAK PRIOR TO THE REPAIR PROCEDURE, ONE DIRECT STICK OF SAC AND ONE CATHETER BASED. THIS LIKELY CAUSED THE MID GRAFT TYPE IIIB ENDOLEAK. THE PROCEDURE RELATED HARM IDENTIFIED WAS A URINARY COMPLICATION (TRAUMATIC FOLEY CATHETER INSERTION). THE PATIENT WAS DISCHARGED ON POST OPERATIVE DAY TWO HOME IN GOOD CONDITION. 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.

    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) 2021. A RECENT FOLLOW UP COMPUTED TOMOGRAPHY (CT) SHOWED AN UNKNOWN ENDOLEAK, EITHER A TYPE IIIB ENDOLEAK OR A TYPE II ENDOLEAK. IT WAS REPORTED THAT THE PATIENT WAS PREVIOUSLY TREATED FOR A TYPE II ENDOLEAK ON TWO SEPARATE OCCASIONS, ONE WAS A DIRECT STICK OF ANEURYSM SAC AND THE OTHER WAS CATHETER BASED TREATMENT ON UNKNOWN DATES. THE PATIENT RETURNED FOR INTERVENTION AND A TYPE IIIB ENDOLEAK WAS FOUND ON CONTRAST ENHANCED ULTRASOUND, HOWEVER IT WAS REPORTED THAT THIS MAY HAVE BEEN CAUSED BY THE DIRECT STICKING OF THE ANEURYSM SAC WHEN THE PHYSICIAN WAS TREATING THE PREVIOUSLY DETECTED TYPE II ENDOLEAK ON AN UNKNOWN DATE. THE PHYSICIAN IMPLANTED TWO OVATION IX ILIAC LIMBS AND THE TYPE IIIB ENDOLEAK WAS RESOLVED. THE PATIENT WAS REPORTED AS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1270765 ALTO MAIN BODY MIH ENDOLOGIX SANTA ROSA TV-AB3480-N FS011821-40 M701TVAB3480N1

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Unknown Required Intervention OVATION IX ILIAC LIMB, LOT# FS021921-22.| OVATION IX ILIAC LIMB, LOT# FS061520-20.| OVATION PRIME FILL POLYMER: LOT# FF102320-01.