BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALTO

    MDR report key: 19910208 · Received August 5, 2024

    Report

    Report Number
    3008011247-2024-00088
    Event Type
    Malfunction
    Date Received
    August 5, 2024
    Date of Event
    July 5, 2024
    Report Date
    July 10, 2024
    Manufacturer
    ENDOLOGIX SANTA ROSA
    Product Code
    MIH
    UDI-DI
    00850007370916
    PMA / PMN Number
    P120006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. THERE ARE NO OTHER EQUIVALENT ADVERSE EVENTS/INCIDENTS FOR THIS LOT NUMBER EXISTING WITHIN THE ENDOLOGIX COMPLAINT HANDLING SYSTEM. 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 POLYMER INCOMPLETE FILL (NO POLYMER IN IPSILATERAL 3RD AND 4TH RINGS, SUPPORT RING AND ALL CONTRALATERAL RINGS) AND INTRAOPERATIVE TYPE IA ENDOLEAK (RESOLVED) COMPLAINTS ARE UNCONFIRMED. THIS IS NOT 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 REMAINS UNKNOWN. THE FINAL PATIENT STATUS WAS NOT REPORTED TO ENDOLOGIX. 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 BEING TREATED FOR ABDOMINAL AORTIC ANEURYSM ON (B)(6) 2024 WITH THE IMPLANT OF AN ALTO ABDOMINAL STENT GRAFT SYSTEM. AFTER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) ON BOTH LEGS, THE ALTO MAIN BODY WAS INSERTED FROM THE RIGHT ACCESS. DURING POLYMER INJECTION, THE POLYMER FILLED VERY SLOWLY. THE POLYMER FILL STOPPED WHILE 10CC STILL REMAINED IN THE SYRINGE. POLYMER WAS OBSERVED IN THE IPSILATERAL 1ST AND 2ND RINGS AND A PART OF SEALING RING; HOWEVER, NO POLYMER WAS APPARENT IN IPSILATERAL 3RD AND 4TH RINGS, SUPPORT RING AND ALL CONTRALATERAL RINGS. BOTH LIMBS WERE THEN IMPLANTED. AN ANGIOGRAPHY WAS TAKEN THAT SHOWED A TYPE IA ENDOLEAK. THE PHYSICIAN DECIDED TO ADD A GORE (NON-ENDOLOGIX) EXCLUDER CUFF TO THE PROXIMAL PORTION OF THE GRAFT. THE TYPE 1A ENDOLEAK WAS RESOLVED INTRAOPERATIVELY, AND THE OPERATION WAS COMPLETED. THE FINAL PATIENT STATUS WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2274098 ALTO MAIN BODY MIH ENDOLOGIX SANTA ROSA TV-AB3480-N FS120123-26 00850007370916

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other OVATION PRIME FILL POLYMER (LN FF080423-03).