BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 2982298 · Received February 25, 2013

    Report

    Report Number
    3008011247-2013-00002
    Event Type
    Injury
    Date Received
    February 25, 2013
    Date of Event
    December 17, 2012
    Report Date
    January 27, 2013
    Manufacturer
    TRIVASCULAR, INC.
    Product Code
    MIH
    PMA / PMN Number
    P120006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE SUBJECT UNDERWENT ENDOVASCULAR REPAIR OF AAA USING THE TRIVASCULAR OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM ON (B)(6) 2012. THE ROUTINE FOLLOW-UP COMPLETED ON (B)(6) 2012 WAS UNEVENTFUL. ON (B)(6) 2012, THE SUBJECT PRESENTED WITH ISCHEMIA OF THE LEFT LEG AS A RESULT OF AN ACUTE VESSEL OCCLUSION OF THE LEFT LIMB OF THE STENT GRAFT, DOWNSTREAM VESSELS, AND THE FEMORAL BIFURCATION. THE PHYSICIAN REPORTED THAT THE THROMBOSIS IN THE LIMB DEVELOPED AFTER PROGRESSION OF PRE-EXISTING PERIPHERAL ARTERY DISEASE IN THE ILIAC ARTERY, AND THE SECONDARY PARTS OF THE MURAL THROMBUS IN THE ILIAC LIMB GRAFT EMBOLIZED. A RE-INTERVENTION WAS COMPLETED ON (B)(6) 2012 TO PERFORM A THROMBECTOMY OF THE LEFT LIMB WITH AN IMPLANTATION OF ANOTHER STENT GRAFT, AND A SURGICAL DISOBLITERATION OF THE LEFT FEMORAL BIFURCATION. THE POSTOPERATIVE DIAGNOSTICS SHOWED A GOOD RESULT. THE PATIENT WAS DISCHARGED ON (B)(6) 2012 WITHOUT FURTHER SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    79372 OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM ENDOVASCULAR GRAFT, AORTIC ANEURYSM MIH TRIVASCULAR, INC. TV-IL1410120-D FS042312-15

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Other