BEUDAMED
    FDA Adverse Event Other Summary report: N

    OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 3783530 · Received April 15, 2014

    Report

    Report Number
    3008011247-2014-00019
    Event Type
    Other
    Date Received
    April 15, 2014
    Date of Event
    April 28, 2014
    Report Date
    May 19, 2014
    Manufacturer
    TRIVASCULAR, INC.
    Product Code
    MIH
    PMA / PMN Number
    P120006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT RETURNED FOR A FOLLOW-UP CT ON (B)(6) 2014. BASED ON A REVIEW COMPLETED BY TRIVASCULAR ON (B)(6) 2014, THE ENDOLEAK WAS DETERMINED TO BE A TYPE II ENDOLEAK AND NOT A TYPE IA. TYPE II ENDOLEAKS ARE NOT CONSIDERED TO BE RELATED TO THE DEVICE BUT RATHER RELATED TO THE ANATOMY. THERE HAVE BEEN NO ADVERSE PATIENT SEQUELAE REPORTED. REMAINS IMPLANTED.

    Description of Event or Problem · 1

    THE PT UNDERWENT ENDOVASCULAR REPAIR OF AAA WITH THE OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM ON (B)(6) 2014. THE AORTIC BODY AND ILIAC LIMBS WERE DEPLOYED AS EXPECTED. UPON FINAL ANGIO, AN ENDOLEAK WAS OBSERVED NEAR THE PROXIMAL SEALING RINGS. THE PHYSICIAN COULD NOT DETERMINE IF THE ENDOLEAK WAS A TYPE IA OR A TYPE II. THE SEALING RINGS WERE BALLOONED WITH A COMPLIANT BALLOON AND THE ENDOLEAK DID NOT RESOLVE. THE PHYSICIAN ELECTED TO MONITOR THE ENDOLEAK AT A FOLLOW-UP PT VISIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230827 OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM ENDOVASCULAR GRAFT, AORTIC ANEURYSM MIH TRIVASCULAR, INC. TV-AB2680-D FS111413-42

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other