BEUDAMED
    FDA Adverse Event Other Summary report: N

    OVATION ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 3535772 · Received November 25, 2013

    Report

    Report Number
    3008011247-2013-00053
    Event Type
    Other
    Date Received
    November 25, 2013
    Date of Event
    October 30, 2013
    Report Date
    October 30, 2013
    Manufacturer
    TRIVASCULAR INC
    Product Code
    MIH
    PMA / PMN Number
    P120006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    GRAFT LEG. AN INFOLD IS PRESENT AT THE SEALING RING, POSSIBLY DUE TO OVERSIZING OF THE STENT GRAFT AND CONTRIBUTING TO THE TYPE IA ENDOLEAK.

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT ENDOVASCULAR REPAIR OF AAA WITH THE OVATION ABDOMINAL STENT GRAFT SYSTEM ON (B)(6) 2013. IT WAS REPORTED THAT THERE WAS AN OBSTRUCTION IN THE DELIVERY SYSTEM FILL POLYMER LUMEN RESULTING IN DIFFICULTIES FILLING THE AORTIC BODY GRAFT. THE PROCEDURE WAS COMPLETED WITHOUT THE COMPLETE POLYMER FILL AND CONTRAST WAS USED TO FILL THE GRAFT FOR VISUALIZATION. A TYPE IA ENDOLEAK WAS PRESENT AT THE END OF THE PROCEDURE, WHICH THE PHYSICIAN ELECTED TO EVALUATE AT A LATER DATE. THE RETURNED DEVICE WAS EVALUATED AND A ROOT CAUSE FOR THE DIFFICULTY FILLING THE STENT GRAFT COULD NOT BE DETERMINED. THE INOPERATIVE IMAGES WERE REVIEWED AND THE SEALING RING APPEARS TO BE NOMINALLY FILLED WITH POLYMER, WITH A KINK IN THE FILL CHANNEL OF THE AORTIC BODY LEG OF THE STENT GRAFT POSSIBLY RESULTING FROM ATTEMPTED PROXIMAL REPOSITIONING OF THE GRAFT DURING THE PROCEDURE OR THE INFLUENCE OF INFRARENAL ANGULATION NEAR THE AORTIC BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    614467 OVATION ABDOMINAL STENT GRAFT SYSTEM ENDOVASCULAR GRAFT, AORTIC ANEURYSM MIH TRIVASCULAR INC TV-AB2980-B FS092911-03

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Other