BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 3800987 · Received May 8, 2014

    Report

    Report Number
    3008011247-2014-00025
    Event Type
    Injury
    Date Received
    May 8, 2014
    Date of Event
    April 8, 2014
    Report Date
    April 8, 2014
    Manufacturer
    TRIVASCULAR, INC.
    Product Code
    MIH
    PMA / PMN Number
    P120006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE 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. FOLLOWING SUCCESSFUL DEPLOYMENT OF THE AORTIC BODY AND ILIAC LIMB DEVICES, THE FINAL ANGIOGRAM REVEALED THE PRESENCE OF A TYPE IA ENDOLEAK, WHICH DID NOT RESOLVE WITH THE USE OF AN ANGIOPLASTY BALLOON OR THE PLACEMENT OF A STENT IN THE SEAL ZONE. ACCORDING TO PRE-PROCEDURE IMAGING, THE AORTIC DIAMETER WAS ON THE LARGER END OF THE TREATMENT RANGE AND THROMBUS WAS PRESENT FROM MID-ANEURYSM TO THE NATIVE BIFURCATION. AS OF THE DATE OF THIS REPORT, THE PATIENT CONTINUES TO BE MONITORED AND THERE HAS BEEN NO RE-INTERVENTION; THE PATIENT IS ASYMPTOMATIC WITH NO ADVERSE SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277321 OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM ENDOVASCULAR GRAFT, AORTIC ANEURYSM MIH TRIVASCULAR, INC. TV-AB3480-E FS012314-25

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Other PALMAZ STENT