BEUDAMED
    FDA Adverse Event Death Summary report: N

    OVATION PRIME AORTIC BODY STENT GRAFT SYSTEM

    MDR report key: 6358238 · Received February 24, 2017

    Report

    Report Number
    3008011247-2017-00021
    Event Type
    Death
    Date Received
    February 24, 2017
    Date of Event
    November 23, 2016
    Report Date
    January 25, 2017
    Manufacturer
    TRIVASCULAR, INC.
    Product Code
    MIH
    UDI-DI
    M701TVAB2380D1
    PMA / PMN Number
    P120006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE REMAINS IMPLANTED.

    Additional Manufacturer Narrative · 1

    BASED ON THE CLINICAL ASSESSMENT FOR THIS EVENT, THE MOST LIKELY CAUSE OF THE REPORTED ANEURYSM GROWTH AND INFECT AORTA WAS DETERMINED TO BE UNKNOWN/UNDETERMINED. A CLINICAL ASSESSMENT SHOWED THAT THE DEVICE DID NOT LIKELY CONTRIBUTE TO THIS EVENT. THE LEFT GROIN INFECTION WITHIN 30 DAYS OF THE REPAIR PROCEDURE IS REFLECTIVE OF A PROCEDURE-RELATED HARM. THE NEGATIVE SEQUELAE WAS ALSO EXACERBATED BY THE COMPLEXITY OF THE REPAIR PROCEDURE DUE TO THE PATIENT'S PRE-EXISTING FEMORAL ANATOMY. OFF-LABEL OR CAUTIONARY PRODUCT USE CONDITIONS COULD NOT BE DETERMINED. A REVIEW OF THE DEVICE QUALITY RECORDS SHOWS THAT THE DEVICE DEMONSTRATED COMPLIANCE TO ESTABLISHED PROCEDURES AND SPECIFICATIONS AT THE TIME OF MANUFACTURE. (B)(4).

    Description of Event or Problem · 1

    AN OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM. THE 1 YEAR POST-OPERATIVE CT SHOWED THE PRESENCE OF A POTENTIAL TYPE IA AND/OR TYPE II ENDOLEAK IN THE PRESENCE OF SIGNIFICANT JUXTARENAL ANGULATION AND CALCIUM IN THE SEAL ZONE. AS OF THE DATE OF THIS REPORT, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED AND THE PATIENT WILL CONTINUE TO BE MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139204 OVATION PRIME AORTIC BODY STENT GRAFT SYSTEM ENDOVASCULAR GRAFT, ABDOMINAL AORTIC ANEURYSM MIH TRIVASCULAR, INC. TV-AB2380-D FS052115-20 M701TVAB2380D1

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other