BEUDAMED
    FDA Adverse Event Death Summary report: N

    OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 3783519 · Received April 15, 2014

    Report

    Report Number
    3008011247-2014-00018
    Event Type
    Death
    Date Received
    April 15, 2014
    Date of Event
    March 19, 2014
    Report Date
    March 19, 2014
    Manufacturer
    TRIVASCULAR, INC.
    Product Code
    MIH
    PMA / PMN Number
    P120006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON A REVIEW OF THE PRE-OP CT AND PERIPROCEDURAL IMAGING, THERE IS INFRARENAL VESSEL ANGULATION PRESENT AT THE LOCATION OF THE AORTIC BODY FILL CHANNEL PINCH POINT AND EVIDENCE OF TWISTING OF THE GRAFT LEG. INSPECTION OF THE RETURNED CATHETER SHOWED NO EVIDENCE OF A POLYMER FILL CHANNEL OBSTRUCTION, HOWEVER, THERE IS EVIDENCE OF TORSIONAL FORCE APPLIED TO THE CATHETER OUTER SHEATH. THE POTENTIAL TWISTING OF THE CATHETER IS CONSISTENT WITH THE TWISTING OBSERVED IN THE AORTIC BODY GRAFT LEG OBSERVED IN THE CASE IMAGING. THE COMBINATION OF TWISTING OF THE AORTIC BODY GRAFT LEG AND IMPINGEMENT BY THE FOCAL VESSEL ANGULATION MAY HAVE LEAD TO OBSTRUCTION IN THE GRAFT FILL POLYMER CHANNEL, RESULTING IN A LACK OF COMPLETE FILLING OF THE GRAFT. THIS INCIDENT DOES NOT APPEAR TO BE A RESULT OF A DEVICE DEFECT.

    Description of Event or Problem · 1

    THE PT UNDERWENT ENDOVASCULAR REPAIR OF AAA WITH THE OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM ON (B)(6) 2011. DURING INJECTION OF THE FILL POLYMER INTO THE AORTIC BODY STENT GRAFT, ONLY THE FIRST THREE RINGS ON THE IPSILATERAL LEG OF THE STENT GRAFT WERE FILLED WITH POLYMER. ATTEMPTS BY THE PHYSICIAN TO RESOLVE THE INCOMPLETE FILLING OF THE GRAFT WERE UNSUCCESSFUL. FOLLOWING SUCCESSFUL DEPLOYMENT OF THE IPSILATERAL ILIAC LIMB, THE PHYSICIAN WAS UNABLE TO ACCESS AND CANNULATE THE CONTRALATERAL GATE OF THE AORTIC BODY STENT GRAFT DUE TO THE INCOMPLETE FILL CONDITION. THE PHYSICIAN SUBSEQUENTLY DETERMINED THAT THE PROCEDURE COULD NOT BE COMPLETED ENDOVASCULARLY AND CONVERTED THE PT TO OPEN SURGICAL REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230825 OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM ENDOVASCULAR GRAFT, AORTIC ANEURYSM MIH TRIVASCULAR, INC. TV-AB3480-D FS110612-06

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Death