BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 3836950 · Received May 28, 2014

    Report

    Report Number
    3008011247-2014-00028
    Event Type
    Malfunction
    Date Received
    May 28, 2014
    Date of Event
    April 30, 2014
    Report Date
    April 30, 2014
    Manufacturer
    TRIVASCULAR, INC.
    Product Code
    MIH
    PMA / PMN Number
    P120006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DELIVERY SYSTEM WAS RETURNED FOR EVALUATION; THE STENT GRAFT WAS NOT AVAILABLE FOR EVALUATION AS IT REMAINS IMPLANTED.

    Description of Event or Problem · 1

    THE SUBJECT UNDERWENT ENDOVASCULAR REPAIR OF AAA USING THE OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM ON (B)(6) 2014. UPON INITIATION OF POLYMER FILL OF THE AORTIC BODY GRAFT, NO FILL POLYMER ENTERED THE GRAFT. THE PHYSICIAN USED ADDITIONAL METHODS TO FILL THE GRAFT INCLUDING USE OF A SECOND FILL POLYMER KIT AND HAND INFLATION WHICH DID NOT FILL THE GRAFTL. AFTER APPROXIMATELY FIVE MINUTES, THE PHYSICIAN COMPLETED THE CASE WITHOUT FILL POLYMER AND IMPLANTED A STENT IN THE SEAL ZONE USING AN AORTIC BALLOON, FOLLOWED BY THE PLACEMENT OF THE ILIAC LIMBS. THE ANEURYSM WAS SUCCESSFULLY EXCLUDED WITH NO ADVERSE PATIENT SEQUELAE. THE RETURNED AORTIC BODY DELIVERY SYSTEM AND AUTOINJECTOR WERE EVALUATED, AND THE CAUSE FOR THE NO POLYMER FILL COULD NOT BE IDENTIFIED. BECAUSE THE AORTIC BODY STENT GRAFT REMAINS IMPLANTED, IT COULD NOT BE EVALUATED. THEREFORE, A ROOT CAUSE FOR THE DIFFICULTIES TO FILL THE AORTIC BODY GRAFT COULD NOT BE DETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313927 OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM ENDOVASCULAR GRAFT, AORTIC ANEURYSM MIH TRIVASCULAR, INC. TV-AB2680-E FS122013-11

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Other PALMAZ STENT