BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 3936624 · Received July 15, 2014

    Report

    Report Number
    3008011247-2014-00047
    Event Type
    Malfunction
    Date Received
    July 15, 2014
    Date of Event
    June 16, 2014
    Report Date
    June 16, 2014
    Manufacturer
    TRIVASCULAR, INC.
    Product Code
    MIH
    PMA / PMN Number
    P120006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT ENDOVASCULAR REPAIR OF AAA USING THE OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM ON (B)(6) 2014. THE AORTIC BODY GRAFT WAS DEPLOYED AS EXPECTED, AND POLYMER FILL WAS INITIATED. APPROXIMATELY 30-45 SECONDS INTO THE POLYMER FILLING OF THE STENT GRAFT, THE FILL POLYMER SYRINGE WAS OBSERVED TO HAVE EMPTIED AND THE PATIENT EXPERIENCED HYPOTENSION WHICH WAS STABILIZED FOLLOWING TREATMENT FOR A RADIOCONTRAST AGENT ALLERGY IN ACCORDANCE WITH THE DEVICE IFU. IT WAS NOTED THAT THE PATIENT HAD BEEN GIVEN VASOCONSTRICTORS PRIOR TO THE IMPLANT PROCEDURE DUE TO UNSTABLE BLOOD PRESSURE. THE STENT GRAFT FILL CHANNELS APPEARED TO CONTAIN ADEQUATE POLYMER WITH GOOD APPOSITION TO THE AORTIC WALL WITH THE ANEURYSM SUCCESSFULLY EXCLUDED. INTRAOPERATIVE IMAGING WAS NOT AVAILABLE FOR REVIEW BY TRIVASCULAR; NO DEVICE INTEGRITY ISSUES WERE OBSERVED DURING EXAMINATION OF THE RETURNED DELIVERY SYSTEM AND A ROOT CAUSE COULD NOT BE DETERMINED. AS OF THE DATE OF THIS REPORT, THE PATIENT IS REPORTED AS DOING WELL AND THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    413568 OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM ENDOVASCULAR GRAFT, ABDOMINAL AORTIC ANEURYSM MIH TRIVASCULAR, INC. TV-AB2980-D FS031714-16

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention