BEUDAMED
    FDA Adverse Event Death Summary report: N

    OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 4940657 · Received July 24, 2015

    Report

    Report Number
    3008011247-2015-00076
    Event Type
    Death
    Date Received
    July 24, 2015
    Date of Event
    June 24, 2015
    Report Date
    June 24, 2015
    Manufacturer
    TRIVASCULAR, INC.
    Product Code
    MIH
    PMA / PMN Number
    P120006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 1

    AN OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM. UPON POLYMER FILLING OF THE AORTIC BODY STENT GRAFT, THE PRIMARY SEALING RING APPEARED COMPRESSED AND IN-FOLDED DUE TO THE AORTIC BODY STENT GRAFT SIZE WITH A LARGER DIAMETER THAN THE VESSEL TREATMENT RANGE. THE FINAL ANGIOGRAM SHOWED THE PRESENCE OF A TYPE IA ENDOLEAK THAT COULD NOT BE RESOLVED FOLLOWING BALLOONING. A BALLOON EXPANDABLE STENT WAS ADVANCED TO THE SEAL ZONE, AND AFTER INFLATION OF THE BALLOON, THE PATIENT'S BLOOD PRESSURE WAS OBSERVED TO HAVE DROPPED AND EXTRAVASATION OF THE VESSEL WAS OBSERVED DISTAL TO THE LEFT RENAL ARTERY INDICATIVE OF AN AORTIC RUPTURE. THREE AORTIC CUFFS, ONE OF WHICH WAS PLACED TO INTENTIONALLY COVER THE LEFT RENAL ARTERY, AND TWO COVERED BALLOON EXPANDABLE STENTS WERE IMPLANTED AT THE LEVEL OF THE SEAL ZONE AND THE LOCATION OF THE RUPTURE SUCCESSFULLY RESOLVING THE TYPE IA ENDOLEAK AND AORTIC RUPTURE. THE PATIENT SUBSEQUENTLY EXPIRED THREE DAYS FOLLOWING THE IMPLANT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    483137 OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM ENDOVASCULAR GRAFT, ABDOMINAL AORTIC ANEURYSM MIH TRIVASCULAR, INC. TV-AB3480-E FS052114-35

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Death| R VIABAHN STENT (X2)| PALMAZ STENT| GORE CUFF (X3)| RENAL STENT (X2)