BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OVATION IX

    MDR report key: 8626084 · Received May 20, 2019

    Report

    Report Number
    3008011247-2019-00082
    Event Type
    Malfunction
    Date Received
    May 20, 2019
    Date of Event
    April 24, 2019
    Report Date
    April 24, 2019
    Manufacturer
    ENDOLOGIX (TRIVASCULAR INC.)
    Product Code
    MIH
    UDI-DI
    M701TVAB3480J1
    PMA / PMN Number
    P120006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CLINICAL ASSESSMENT OF THE REPORTED EVENT WAS UNABLE TO BE COMPLETED DUE TO A LACK OF RECEIPT OF RELEVANT MEDICAL RECORDS AND/OR IMAGING. REQUESTS WERE MADE; HOWEVER, A DENIED RESPONSE WAS RECEIVED FOR MEDICAL RECORDS AND NO RESPONSE WAS RECEIVED FOR MEDICAL IMAGING. AS SUCH, EVENT DETERMINATION, OFF LABEL CONDITIONS, RELATED PATIENT HARMS AND PATIENT DISPOSITION COULD NOT BE ASSESSED. THE DEVICE REMAINS IMPLANTED; THEREFORE, NO DEVICE EVALUATION WAS COMPLETED. THE MANUFACTURING LOT EVALUATION CONFIRMED ALL DEVICES MET SPECIFICATIONS PRIOR TO RELEASE. NO ADDITIONAL INVESTIGATION OF THIS REPORTED EVENT IS PLANNED; HOWEVER, IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED. ENDOLOGIX WILL CONTINUE TO MONITOR THIS COMPLAINT AND SIMILAR COMPLAINTS IN THE EVENT FURTHER INVESTIGATION IS NEEDED.

    Additional Manufacturer Narrative · 1

    ENDOLOGIX WILL CONTINUE TO INVESTIGATE THE REPORTED EVENT. THE PATIENT MEDICAL RECORDS AND IMAGING STUDIES HAVE BEEN REQUESTED FOR FURTHER EVALUATION BY A CLINICAL SPECIALIST. A FINAL REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION OF THE REPORTED EVENT HAS CONCLUDED.

    Description of Event or Problem · 1

    THE PATIENT WAS INITIALLY TREATED WITH THE OVATION IX ABDOMINAL STENT GRAFT SYSTEM TO TREAT AN ABDOMINAL AORTIC ANEURYSM. THE AORTIC MAIN BODY LANDED AND DEPLOYED AS EXPECTED HOWEVER, A TYPE IA ENDOLEAK WAS OBSERVED. A PALMAZ STENT WAS PLACED AT THE LEVEL OF THE SEALING RINGS WHICH SUCCESSFULLY RESOLVED THE INTRA-OPERATIVE TYPE IA ENDOLEAK. ADDITIONALLY, DURING DELIVERY AND DEPLOYMENT OF THE ILIAC LIMBS IT WAS NOTED THAT THE LIMBS MAY HAVE INADVERTENTLY BEEN DEPLOYED OUTSIDE THE AORTIC MAIN BODY LEG ON THE CONTRA SIDE OR ONE LIMB MAY HAVE BEEN DEPLOYED OUTSIDE THE AORTIC ''MAY'' BODY LEG. DUE TO POOR IMAGING AND PATIENT ANATOMY VISIBILITY COULD NOT DEFINITIVELY CONFIRM WHICH. A DECISION WAS MADE TO IMPLANT AN ADDITIONAL OVATION IX LIMB; PLACED INTO THE AORTIC MAIN BODY CONTRA LEG AND NEXT TO THE EXISTING IN-DWELLING LIMB. POST DILATATION WITH A 12 X 4 MM NON-ENDOLOGIX BALLOON WAS PERFORMED THROUGHOUT BOTH LIMBS. FINAL RUNS SHOWED NO PRESENCE OF AN ENDOLEAK OF ANY TYPE AND ADEQUATE FLOW. THE PATIENT TOLERATED THE PROCEDURE WELL HOWEVER, DEVELOPED COLD LEGS RELATED TO COMPLICATIONS WHICH WERE REPORTED AS UNRELATED TO THE ENDOLOGIX DEVICE. BILATERAL STENTING IN BOTH COMMON FEMORAL ARTERIES RESOLVED THE ADDITIONAL UNRELATED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    417446 OVATION IX MAIN BODY MIH ENDOLOGIX (TRIVASCULAR INC.) TV-AB3480-J FS092418-25 M701TVAB3480J1

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other OVATION IX ILIAC LIMB (LN FS102518-35).| OVATION IX ILIAC LIMB (LN FS110218-29).| OVATION IX ILIAC LIMB (LN FS111018-66).| PALMAZ (NON-ENDOLOGIX) PART/LOT UNK.