BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 3897343 · Received June 26, 2014

    Report

    Report Number
    3008011247-2014-00039
    Event Type
    Injury
    Date Received
    June 26, 2014
    Date of Event
    May 29, 2014
    Report Date
    May 29, 2014
    Manufacturer
    TRIVASCULAR, INC.
    Product Code
    MIH
    PMA / PMN Number
    P1200006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT SUCCESSFUL ENDOVASCULAR REPAIR OF AAA USING THE OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM ON (B)(6) 2014. AT THE 6-MONTH FOLLOW-UP VISIT, CT IMAGING INDICATED THE PRESENCE OF A TYPE IA ENDOLEAK. A LARGE AMOUNT OF IRREGULARLY SHAPED THROMBUS IN THE AORTIC SEALING ZONE WAS NOTED IN THE PRE-TREATMENT CT IMAGING, AND THE MORPHOLOGY OF THE THROMBUS HAD CHANGED SIGNIFICANTLY AT THE 6-MONTH FOLLOW-UP CT. IN THE ABSENCE OF INTRA-OPERATIVE AND/OR POST-PROCEDURAL IMAGING, A DEFINITIVE CAUSE FOR THE ENDOLEAK AND/OR THE POTENTIAL ROLE OF MORPHOLOGICAL CHANGES IN THE THROMBUS COULD NOT BE DETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    373577 OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM ENDOVASCULAR GRAFT, ABDOMINAL AORTIC ANEURYSM MIH TRIVASCULAR, INC. TV-AB2380-D FS041913-01

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other