BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 3913142 · Received June 11, 2014

    Report

    Report Number
    3008011247-2014-00031
    Event Type
    Injury
    Date Received
    June 11, 2014
    Date of Event
    May 12, 2014
    Report Date
    May 12, 2014
    Manufacturer
    TRIVASCULAR, INC
    Product Code
    MIH
    PMA / PMN Number
    P120006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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 AORTIC BODY DELIVERY SYSTEM WAS ADVANCED AND DEPLOYED AS EXPECTED. IT WAS NOTED THAT THE CONTRALATERAL GATE WAS POSITIONED POSTERIOR AND THAT THE PHYSICIAN HAD DIFFICULTIES TORQUING THE DEVICE, POSSIBLY DUE TO THE PRESENCE OF SIGNIFICANT CALCIUM AND TORTUOSITY. THE PHYSICIAN EXPERIENCED DIFFICULTIES CANNULATING THE CONTRALATERAL GATE OF THE AORTIC BODY GRAFT; AN UP AND OVER APPROACH BY THE PHYSICIAN ULTIMATELY ACHIEVED CONTRALATERAL GATE ACCESS AND SUCCESSFUL ANEURYSM EXCLUSION AFTER A PROLONGED PROCEDURE TIME. THERE WERE NO PT SEQUELAE AS A RESULT OF THIS EVENT. BECAUSE NEITHER THE DELIVERY SYSTEM NOR INTRAOPERATIVE IMAGING WERE AVAILABLE FOR REVIEW, A DEFINITIVE ROOT CAUSE FOR THE CANNULATION DIFFICULTIES COULD NOT BE DETERMINED; HOWEVER, THE SIGNIFICANT CALCIFICATION AND THROMBUS IN THE AORTA MAY HAVE BEEN CONTRIBUTING FACTORS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343877 OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM ENDOVASCULAR GRAFT, AORTIC ANEURYSM MIH TRIVASCULAR, INC V-AB2680-E FS070313-25

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other