BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 3878531 · Received June 17, 2014

    Report

    Report Number
    3008011247-2014-00033
    Event Type
    Injury
    Date Received
    June 17, 2014
    Date of Event
    April 29, 2014
    Report Date
    May 19, 2014
    Manufacturer
    TRIVASCULAR, INC.
    Product Code
    MIH
    PMA / PMN Number
    P120006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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. THE PATIENT RETURNED FOR THE 3 MONTH FOLLOW-UP CT ON (B)(6) 2014, AND PRESENTED WITH AN OCCLUSION OF THE LEFT ILIAC LIMB. A REVIEW OF THE POST-OPERATIVE IMAGING SHOWS THAT THE ILIAC LIMBS ARE TWISTED A FULL 270 DEGREES. THE SIGNIFICANT ROTATION OF THE ILIAC LIMBS DURING THE ORIGINAL IMPLANT PROCEDURE MAY HAVE CAUSED THE LEFT ILIAC LIMB TO BECOME COMPRESSED, RESULTING IN A COMPLETE OCCLUSION OVER TIME. AS OF THE DATE OF THIS REPORT, THE PHYSICIAN PLANS TO MONITOR THE PATIENT. THE LEFT EXTERNAL ILIAC ARTERY IS BEING PERFUSED BY THE LEFT HYPOGASTRIC ARTERY THEREFORE, THERE IS NO PLAN FOR A RE-INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    355405 OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM ENDOVASCULAR GRAFT, ABDOMINAL AORTIC ANEURYSM MIH TRIVASCULAR, INC. TV-IL1416140-D FS091813-34

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Other