BEUDAMED
    FDA Adverse Event Other Summary report: N

    OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 3576961 · Received January 2, 2014

    Report

    Report Number
    3008011247-2014-00001
    Event Type
    Other
    Date Received
    January 2, 2014
    Date of Event
    December 5, 2013
    Report Date
    December 5, 2013
    Manufacturer
    TRIVASCULAR, INC.
    Product Code
    MIH
    PMA / PMN Number
    P120006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PT UNDERWENT ENDOVASCULAR REPAIR OF AAA WITH THE OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM ON (B)(6) 2013. THE PT HAD NARROW ACCESS VESSELS AND THE AORTIC BODY DELIVERY SYSTEM WAS KEPT IN POSITION WITHIN THE AORTA APPROX 40 MINS PRIOR TO DEMATING FROM THE GRAFT. FOLLOWING CATHETER WITHDRAWAL, THE PT EXPERIENCED HYPOTENSION AND THE PHYSICIAN TREATED THE PT FOR AN ALLERGIC REACTION PER THE IFU, BUT THE PT DID NOT RESPOND. THE PT RESPONDED TO CHEST COMPRESSIONS AND A CODA BALLOON WAS PLACED IN THE SUPRARENAL AORTA TO ASSIST WITH STABILIZING THE BLOOD PRESSURE. WHEN THE PT WAS STABILIZED, THE IPSILATERAL ILIAC LIMB WAS SUCCESSFULLY DEPLOYED. THE FINAL ANGIOGRAM SHOWED A SMALL TYPE I ENDOLEAK WHICH WAS BALLOONED WITH A CODA BALLOON. THE PHYSICIAN DID NOT PERFORM FINAL IMAGING TO CONFIRM IF THE ENDOLEAK RESOLVED. POST-OPERATIVE SWELLING OF THE PT'S FACE AND EXTREMITIES WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2570 OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM ENDOVASCULAR GRAFT, AORTIC ANEURYSM MIH TRIVASCULAR, INC. TV-AB2380-E FS071913-01

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other