BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 4604981 · Received March 16, 2015

    Report

    Report Number
    3008011247-2015-00023
    Event Type
    Injury
    Date Received
    March 16, 2015
    Date of Event
    February 12, 2015
    Report Date
    February 15, 2015
    Manufacturer
    TRIVASCULAR, INC.
    Product Code
    MIH
    PMA / PMN Number
    P120006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REMAINS IMPLANTED.

    Description of Event or Problem · 1

    AN OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM. THE 6 MONTH FOLLOW-UP CT SHOWED THE PRESENCE OF A TYPE IA ENDOLEAK. PRE-TREATMENT CT IMAGING INDICATED THE PRESENCE OF A LARGE AMOUNT OF IRREGULARLY SHAPED THROMBUS IN THE AORTIC SEALING ZONE WITH SIGNIFICANT MORPHOLOGICAL CHANGES IN THROMBUS OBSERVED IN THE 6-MONTH FOLLOW-UP CT. THE PATIENT RETURNED FOR A RE-INTERVENTION ON (B)(6) 2015 WHERE A BALLOON EXPANDABLE STENT AND AN AORTIC CUFF WERE IMPLANTED WITHIN THE AORTIC BODY GRAFT, IN CONJUNCTION WITH A STENT IN THE RENAL ARTERY, SUCCESSFULLY RESOLVING THE TYPE IA 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
    179148 OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM ENDOVASCULAR GRAFT, ABDOMINAL AORTIC ANEURYSM MIH TRIVASCULAR, INC. TV-AB3480-E FS120413-05

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention PALMAZ STENT| ATRIUM STENT| GORE EXCLUDER AORTIC CUFF