BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 3080272 · Received April 24, 2013

    Report

    Report Number
    3008011247-2013-00007
    Event Type
    Injury
    Date Received
    April 24, 2013
    Date of Event
    March 26, 2013
    Report Date
    March 26, 2013
    Manufacturer
    TRIVASCULAR, INC.
    Product Code
    MIH
    PMA / PMN Number
    P120006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE LIMITED INFORMATION PROVIDED FOR THIS EVENT, THE ROOT CAUSE OF THE CANNULATION DIFFICULTIES OF THE IPSILATERAL GATE APPEARS TO HAVE BEEN A RESULT OF THE INADVERTENT LOSS OF GUIDE WIRE ACCESS WHILE ATTEMPTING TO PERFORM A WIRE EXCHANGE. THE ORIGINAL POSITION OF THE AORTIC BODY GRAFT AND OBSERVED TYPE IA ENDOLEAK COULD NOT BE CONFIRMED IN THE ABSENCE OF THE INTRAOPERATIVE IMAGING AND THEREFORE THE ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    SUBJECT UNDERWENT ENDOVASCULAR REPAIR OF AAA WITH THE OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM ON (B)(6) 2013. THE IPSILATERAL ILIAC LIMB DELIVERY SYSTEM WOULD NOT ADVANCE, AND THE NOSECONE PUSHED UP THE IPSILATERAL LEG OF THE AORTIC BODY STENT GRAFT. THE PHYSICIAN INADVERTENTLY LOST GUIDE WIRE ACCESS WHILE ATTEMPTING TO PERFORM A WIRE EXCHANGE RESULTING IN DIFFICULTIES TO REGAIN ACCESS TO THE IPSILATERAL GATE. AFTER ATTEMPTS TO RE-GAIN ACCESS, IT WAS NOTED THAT THE IPSILATERAL LEG OF THE GRAFT HAD FOLDED UPON ITSELF LIMITING WIRE ACCESS. AFTER APPROXIMATELY 45 MINUTES, ACCESS WAS SUCCESSFUL BY USING A COOK OCCLUDER IN THE LEFT COMMON ILIAC FOLLOWED BY THE IMPLANTATION OF THE IPSILATERAL LIMB. THE COMPLETION ANGIO SHOWED A TYPE LA ENDOLEAK AND THE AORTIC BODY GRAFT WAS NOTED TO BE POSITIONED APPROXIMATELY 5-7MM BELOW THE RENALS. THE PROXIMAL SEAL ZONE WAS BALLOONED; HOWEVER, THE ENDOLEAK PERSISTED. AT THAT TIME THE PHYSICIAN DECIDED TO CONVERT TO OPEN SURGERY AND EXPLANTED THE DEVICES. NEITHER THE EXPLANTED DEVICES NOR THE CASE IMAGING WERE PROVIDED TO TRIVASCULAR FOR REVIEW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    177140 OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM ENDOVASCULAR GRAFT, AORTIC ANEURYSM MIH TRIVASCULAR, INC. TV-AB2980-E FS091912-07

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention