BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OVATION IX

    MDR report key: 7589183 · Received June 11, 2018

    Report

    Report Number
    3008011247-2018-00123
    Event Type
    Malfunction
    Date Received
    June 11, 2018
    Date of Event
    May 12, 2018
    Report Date
    May 12, 2018
    Manufacturer
    ENDOLOGIX (TRIVASCULAR INC.)
    Product Code
    MIH
    UDI-DI
    M701TVAB2980I1
    PMA / PMN Number
    P120006
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING LOT EVALUATION CONFIRMED ALL DEVICES MET SPECIFICATIONS PRIOR TO RELEASE. THE DEVICE WAS NOT RETURNED AS THE DEVICE REMAINS IMPLANTED THEREFORE NO EVALUATION WAS COMPLETED. AT THE COMPLETION OF THE CLINICAL ASSESSMENT, CLINICAL WAS ABLE TO FIND SUBSTANTIAL EVIDENCE TO REFUTE THE FOLLOWING REPORTED EVENT OF CREASE / FOLD WITHIN THE UNSUPPORTED BODY PART OF THE MAIN BODY RATHER THE MAIN AORTIC BODY IS TWISTED BELOW THE SECOND SEALING RING. THE COMPLAINT IS MOST LIKELY USER RELATED AS THIS TYPE OF EVENT CAN HAPPEN DUE TO TWISTING THE OUTER CATHETER RELATIVE TO THE INNER OR MORE LIKELY WRAPPING THE GUIDEWIRE AROUND THE INNER CATHETER WHEN GAINING ACCESS TO THE CONTRALATERAL SIDE. THE FINAL PATIENT STATUS WAS REPORTED TO BE IN A STABLE CONDITION AND WILL BE MONITORED. ENDOLOGIX CONTINUES TO INVESTIGATE THIS EVENT AND SIMILAR EVENTS TO ENSURE THE HIGHEST QUALITY AND PATIENT SAFETY

    Description of Event or Problem · 1

    ON (B)(6) 2018, AN OVATION IX ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM. ON (B)(6) 2018, ENDOLOGIX WAS MADE AWARE OF A DECREASE IN BLOOD FLOW BETWEEN THE END OF THE SECONDARY SEALING RING AND THE BEGINNING OF THE ILIAC LIMBS. UPON FURTHER REVIEW OF THE MEDICAL IMAGES, IT WAS NOTED THAT THERE IS A CREASE / FOLD WITHIN THE UNSUPPORTED BODY PART OF THE MAIN BODY. AS OF THE DATE OF THIS REPORT, THE PATIENT IS DOING FINE AND SHOWING NO SYMPTOMS. THERE HAVE BEEN NO SEQUELAE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431680 OVATION IX MAIN BODY MIH ENDOLOGIX (TRIVASCULAR INC.) TV-AB2980-I FS071717-38 M701TVAB2980I1

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| O