BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OVATION IX

    MDR report key: 7443139 · Received April 19, 2018

    Report

    Report Number
    3008011247-2018-00069
    Event Type
    Malfunction
    Date Received
    April 19, 2018
    Date of Event
    March 22, 2018
    Report Date
    March 22, 2018
    Manufacturer
    ENDOLOGIX (TRIVASCULAR INC.)
    Product Code
    MIH
    UDI-DI
    M701TVAB2980J1
    PMA / PMN Number
    P120006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    AT THE COMPLETION OF THE CLINICAL EVALUATION, BASED ON THE INFORMATION RECEIVED THERE WERE SUBSTANTIAL EVIDENCE TO SUPPORT THE REPORTED ENDOLEAK TYPE IA. THE COMPLAINT IS MOST LIKELY ANATOMY RELATED. PROCEDURE RELATED HARMS FOR THIS COMPLAINT COULD NOT BE DETERMINED BASED ON THE INFORMATION SHARED WITH ENDOLOGIX TO REVIEW. THE FINAL PATIENT STATUS WAS REPORTED TO BE AWAITING INTERVENTION FOLLOWING A SECONDARY ENDOVASCULAR PROCEDURE. DEVICES REMAIN IMPLANTED IN THE PATIENT AND WERE NOT RETURNED, NO EVALUATION COMPLETED. THE REVIEW OF MANUFACTURING LOT CONFIRMED ALL DEVICES MET SPECIFICATIONS PRIOR TO RELEASE. THIS COMPLAINT IS NOT CAPA ELIGIBLE AT THIS TIME. THESE TYPES OF EVENTS WILL BE MONITORED AND TRENDED AS PART OF THE QUALITY SYSTEM.

    Additional Manufacturer Narrative · 1

    ENDOLOGIX WILL CONTINUE TO INVESTIGATE THE REPORTED EVENT. THE PATIENT MEDICAL RECORDS AND IMAGING STUDIES WILL BE 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

    AN OVATION IX ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM. AT THE CONCLUSION OF THE INDEX PROCEDURE, A TYPE IA ENDOLEAK WAS NOTED. PHYSICIAN ELECTED TO CONCLUDE THE PROCEDURE AND FOLLOW UP IN ONE WEEK. THE PATIENT RETURNED FOR A FOLLOW UP CT WHERE THE TYPE IA ENDOLEAK WAS STILL OBSERVED. THE PHYSICIAN ELECTED TO RE-INTERVENE BY PLACING A PALMAZ STENT, HOWEVER THE ENDOLEAK WAS NOT RESOLVED. THE PATIENT IS BEING TRANSFERRED TO ANOTHER HOSPITAL TO TREAT THE ENDOLEAK. AS OF THE DATE OF THIS REPORT, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    286927 OVATION IX MAIN BODY MIH ENDOLOGIX (TRIVASCULAR INC.) TV-AB2980-J FS103017-45 M701TVAB2980J1

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Other OVATION IX ILIAC LIMB: TV-IL1418120-J| OVATION IX ILIAC LIMB: TV-IL1422100-J| OVATION IX ILIAC LIMB: TV-IL1418120-J| OVATION IX ILIAC LIMB: TV-IL1422100-J