BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OVATION PRIME

    MDR report key: 10593927 · Received September 28, 2020

    Report

    Report Number
    3008011247-2020-00105
    Event Type
    Malfunction
    Date Received
    September 28, 2020
    Date of Event
    February 2, 2018
    Report Date
    February 12, 2018
    Manufacturer
    ENDOLOGIX SANTA ROSA
    Product Code
    MIH
    PMA / PMN Number
    P120006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED ADVERSE EVENT/INCIDENT WAS INVESTIGATED IN ALIGNMENT WITH ENDOLOGIX OPERATING PROCEDURES AND WORK INSTRUCTIONS. 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 A STENT FRACTURE OF THE MAIN BODY, HOWEVER THE REPORTED STENT GRAFT MIGRATION WAS NOT CONFIRMED. PROCEDURE-RELATED HARMS, DEVICE, USER, PROCEDURE, OR ANATOMY RELATEDNESS OF THIS EVENT COULD NOT BE DETERMINED WITH THE MEDICAL RECORDS AVAILABLE FOR REVIEW. DURING THE INVESTIGATION AND WITH THE INFORMATION AVAILABLE, ENDOLOGIX FOUND NO EVIDENCE TO SUGGEST THE DEVICE WAS USED OFF-LABEL. THE FINAL PATIENT STATUS WAS NOT REPORTED. 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. DEVICES REMAIN IMPLANTED.

    Description of Event or Problem · 1

    THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE OVATION PRIME ABDOMINAL AORTIC ANEURYSM STENT. APPROXIMATELY FIVE (5) YEARS POST INITIAL PROCEDURE, THE PATIENT PRESENTED WITH A STENT FRACTURE AND STENT GRAFT MIGRATION (UNKNOWN DISTANCE). THE PATIENT'S CURRENT CONDITION IS UNKNOWN, AND IT IS UNKNOWN IF THE PHYSICIAN PLANS TO RE-INTERVENE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1057655 OVATION PRIME MAIN BODY MIH ENDOLOGIX SANTA ROSA TV-AB2680-D FS050812-24

    Patients

    Seq Age Sex Outcome Treatment
    1 Other OVATION PRIME ILIAC LIMB, SERIAL #: (B)(4) | OVATION PRIME ILIAC LIMB, SERIAL #: (B)(4)