BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OVATION PRIME

    MDR report key: 8525438 · Received April 17, 2019

    Report

    Report Number
    3008011247-2019-00062
    Event Type
    Injury
    Date Received
    April 17, 2019
    Report Date
    March 20, 2019
    Manufacturer
    ENDOLOGIX (TRIVASCULAR INC.)
    Product Code
    MIH
    UDI-DI
    M701TVAB2980E1
    PMA / PMN Number
    P120006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CLINICAL ASSESSMENT WAS COMPLETED BASED ON THE RECEIVED MEDICAL RECORDS. THE REPORTED EVENTS OF URGENT PRESENTATION, TYPE IA ENDOLEAK, SEVERE LIFESTYLE LIMITING CLAUDICATION, NON-ENDOLOGIX STENT INFOLDING REQUIRING BALLOONING, AND SECONDARY ENDOVASCULAR PROCEDURE ARE UNCONFIRMED DUE TO LACK OF CONTRASTED MEDICAL IMAGING AND OPERATIVE NOTES. THE PLACEMENT OF FENESTRATED NON-ENDOLOGIX STENTS IN THE CELIAC ARTERY, SUPERIOR MESENTERIC ARTERY, BILATERAL RENAL ARTERIES, AND PROXIMAL AORTA IS CONFIRMED. DEVICE, USER, PROCEDURE OR ANATOMY RELATEDNESS OF THESE EVENTS COULD NOT BE DETERMINED. PROCEDURE RELATED HARMS FOR THIS COMPLAINT COULD NOT BE DETERMINED. THE FINAL PATIENT STATUS WAS NOT REPORTED. THE MANUFACTURING LOT EVALUATION WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER WAS UNKNOWN. THE DEVICE REMAINS IMPLANTED; THEREFORE, NO DEVICE EVALUATION WAS COMPLETED. 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

    AN OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY THREE (3) YEARS POST OP, ON AN UNKNOWN DATE IN (B)(6) 2018, THE PATIENT PRESENTED TO THE HOSPITAL WITH ABDOMINAL PAIN AND A SUSPECTED TYPE 1A ENDOLEAK. THE PHYSICIAN TREATED THE PATIENT BY IMPLANTING A NON-ENDOLOGIX (COOK MEDICAL) ZFEN GRAFT ATTEMPTING TO RESOLVE THE TYPE 1A ENDOLEAK. APPROXIMATELY FOUR (4) MONTHS POST RE-INTERVENTION, THE PATIENT PRESENTED TO A SCHEDULED VISIT WITH SEVERE LIFESTYLE LIMITING CLAUDICATION AND NONPALPABLE BILATERAL FEMORAL PULSES. ANGIOGRAM IDENTIFIED SEVERE HIGH GRADE STENOSIS 2CM ABOVE THE FLOW DIVIDER. BALLOONING WAS PERFORMED TO INCREASE BLOOD FLOW. REPORTEDLY, THE EVENT OF STENOSIS WAS DUE TO ENFOLDING OF THE NON-ENDOLOGIX (ZFEN) STENT WITHIN THE OVATION PRIME RINGS AND WAS NOT RELATED TO THE ENDOLOGIX DEVICE. PATIENT HAD PALPABLE FEMORAL PULSES POST ADDITIONAL RE-INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318405 OVATION PRIME MAIN BODY MIH ENDOLOGIX (TRIVASCULAR INC.) TV-AB2980-E FS031015-14 M701TVAB2980E1

    Patients

    Seq Age Sex Outcome Treatment
    1 93 YR Required Intervention OVATION IX ILIAC LIMB (LN FS050815-32).| OVATION IX ILIAC LIMB (LN FS052215-55).