BEUDAMED
    FDA Adverse Event Death Summary report: N

    OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 4546467 · Received February 25, 2015

    Report

    Report Number
    3008011247-2015-00019
    Event Type
    Death
    Date Received
    February 25, 2015
    Date of Event
    February 4, 2015
    Report Date
    February 4, 2015
    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

    Additional Manufacturer Narrative · 1

    DEVICE NOT RELEASED FROM HOSPITAL.

    Description of Event or Problem · 1

    AN OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM. THE ANEURYSM WAS SUCCESSFULLY EXCLUDED AT THE CONCLUSION OF THE INDEX PROCEDURE. THE PATIENT RETURNED TO ANOTHER PHYSICIAN FOR A POST-OPERATIVE FOLLOW-UP VISIT ON AN UNKNOWN DATE PRESENTING WITH A TYPE IA ENDOLEAK. THE PATIENT WAS CONVERTED TO OPEN SURGICAL REPAIR AND THE STENT GRAFT WAS EXPLANTED. A FOLLOW-UP COMMUNICATION RECEIVED FROM THE IMPLANTING PHYSICIAN VIA THE CASE OWNER ON (B)(6) 2015 STATED THAT THE PATIENT WAS NOT A CANDIDATE FOR OPEN SURGERY AND EXPIRED ON AN UNKNOWN DATE FOLLOWING THE CONVERSION TO OPEN SURGICAL REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    132345 OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM ENDOVASCULAR GRAFT, ABDOMINAL AORTIC ANEURYSM MIH TRIVASCULAR, INC. TV-AB2680-E FS031914-37

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Death| R