BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OVATION IX

    MDR report key: 7957686 · Received October 11, 2018

    Report

    Report Number
    3008011247-2018-00219
    Event Type
    Injury
    Date Received
    October 11, 2018
    Date of Event
    September 12, 2018
    Report Date
    September 12, 2018
    Manufacturer
    ENDOLOGIX (TRIVASCULAR INC.)
    Product Code
    MIH
    UDI-DI
    M701TVAB3480J1
    PMA / PMN Number
    P120006
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    AN EVALUATION OF THE REPORTED EVENT COULD NOT BE COMPLETED DUE TO A LACK OF RECEIPT OF RELEVANT MEDICAL RECORDS AND/OR IMAGING. REQUESTS WERE MADE AND DENIED RESPONSES WERE RECEIVED. AS SUCH, EVENT DETERMINATION, OFF LABEL CONDITIONS, RELATED PATIENT HARMS AND PATIENT DISPOSITION COULD NOT BE INDEPENDENTLY ASSESSED. THE REVIEW OF MANUFACTURING LOT CONFIRMED ALL DEVICES MET SPECIFICATIONS PRIOR TO RELEASE. NO ADDITIONAL INVESTIGATIONS OF THIS REPORTED COMPLAINT ARE PLANNED, ENDOLOGIX WILL CONTINUE TO MONITOR THIS COMPLAINT AND SIMILAR COMPLAINTS IN THE EVENT FURTHER INVESTIGATION IS NEEDED.

    Additional Manufacturer Narrative · 1

    THE DEVICE REMAINS IMPLANTED IN THE PATIENT AND WILL NOT BE RETURNED FOR EVALUATION. IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    AN OVATION IX ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM. THERE WAS A PERSISTENT TYPE 1A ENDOLEAK AT THE END OF THE CASE. AFTER DEPLOYMENT THE RINGS WERE BALLOONED AT 19 MINUTES WITH A NON-ENDOLOGIX BALLOON. AN AORTOGRAM WAS PERFORMED POST LIMB IMPLANT REVEALING THE TYPE 1A ENDOLEAK. A NON-ENDOLOGIX STENT WAS IMPLANTED ACROSS THE OVATION IX RINGS. THE LEAK WAS REDUCED; HOWEVER, STILL PRESENT. THE PHYSICIAN DECIDED TO END THE PROCEDURE AND PLANS TO SCAN AT 30 DAYS. PATIENT WAS REPORTED TO BE FINE ONE DAY POST OPERATION. NO ADDITIONAL EVENT OR PATIENT INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    799016 OVATION IX MAIN BODY MIH ENDOLOGIX (TRIVASCULAR INC.) TV-AB3480-J FS053118-25 M701TVAB3480J1

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Other OVATION IX ILIAC LIMB (LN FS060418-69)| OVATION IX ILIAC LIMB (LN FS060518-41)| OVATION IX ILIAC LIMB (LN FS060418-69)| OVATION IX ILIAC LIMB (LN FS060518-41)