BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 4020294 · Received August 19, 2014

    Report

    Report Number
    3008011247-2014-00062
    Event Type
    Injury
    Date Received
    August 19, 2014
    Date of Event
    September 16, 2014
    Report Date
    September 16, 2014
    Manufacturer
    TRIVASCULAR, INC.
    Product Code
    MIH
    PMA / PMN Number
    P120006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT RETURNED FOR A RE-INTERVENTION ON (B)(6), 2014 IN WHICH A BALLOON EXPANDABLE STENT WAS PLACED IN THE PROXIMAL SEAL ZONE OF THE AORTIC BODY STENT GRAFT AND THE TYPE IA ENDOLEAK WAS SUCCESSFULLY RESOLVED WITH NO ADDITIONAL SEQUELAE REPORTED.

    Additional Manufacturer Narrative · 1

    REMAINS IMPLANTED.

    Description of Event or Problem · 1

    AN OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT DURING ENDOVASCULAR REPAIR OF AN ABDOMINAL AORTIC ANEURYSM. THE FINAL ANGIOGRAM SHOWED THE PRESENCE OF A TYPE IA ENDOLEAK WHICH WAS NOT RESOLVED WITH BALLOONING. BECAUSE THE PATIENT WAS REPORTED TO BE UNDER A HIGH DOSE OF HEPARIN, AND PATENT LUMBAR VESSEL(S) WERE NOTED ON THE PRE-OPERATIVE CT IMAGING NEAR THE LEVEL OF THE SEALING RINGS, THE PHYSICIAN ELECTED TO MONITOR THE PATIENT UNTIL CT IMAGING IS TAKEN AT THE 30 DAY FOLLOW-UP VISIT. AS OF THE DATE OF THIS REPORT, THERE HAVE BEEN NO ADDITIONAL CLINICAL SEQUELAE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    497658 OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM ENDOVASCULAR GRAFT, ABDOMINAL AORTIC ANEURYSM MIH TRIVASCULAR, INC. TV-AB2680-E FS040214-49

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Other| R PALMAZ STENT