BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 4487879 · Received February 5, 2015

    Report

    Report Number
    3008011247-2015-00011
    Event Type
    Malfunction
    Date Received
    February 5, 2015
    Date of Event
    December 18, 2014
    Report Date
    January 8, 2015
    Manufacturer
    TRIVASCULAR, INC.
    Product Code
    MIH
    PMA / PMN Number
    P120006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ONLY THE DELIVERY CATHETER WAS RETURNED FOR EVALUATION; THE STENT GRAFT REMAINS IMPLANTED.

    Description of Event or Problem · 1

    AN OVATION PRIME ABDOMINAL STENT GRAFT WAS IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM. THE AORTIC BODY DELIVERY SYSTEM WAS POSITIONED AND THE AORTIC BODY STENT GRAFT DEPLOYED AS EXPECTED. DURING FILL OF THE STENT GRAFT, THE POLYMER SYRINGE EMPTIED AND THE PATIENT EXPERIENCED TRANSIENT HYPOTENSION WHICH WAS TREATED PER THE INSTRUCTIONS FOR USE AND THE PATIENT WAS STABILIZED INTRAOPERATIVELY. THE PHYSICIAN DEPLOYED A BALLOON EXPANDABLE STENT IN THE PROXIMAL SEALING RING REGION OF THE STENT GRAFT TO RESOLVE A TYPE IA ENDOLEAK AND SUCCESSFULLY EXCLUDE THE ANEURYSM. AS OF THE DATE OF THIS REPORT, THERE HAVE BEEN NO ADDITIONAL SEQUELAE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83967 OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM ENDOVASCULAR GRAFT, ABDOMINAL AORTIC ANEURYSM MIH TRIVASCULAR, INC. TV-AB2680-D FS031714-37

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention PALMAZ STENT