BEUDAMED
    FDA Adverse Event Death Summary report: N

    OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 3376523 · Received September 25, 2013

    Report

    Report Number
    3008011247-2013-00035
    Event Type
    Death
    Date Received
    September 25, 2013
    Date of Event
    August 22, 2013
    Report Date
    August 30, 2013
    Manufacturer
    TRIVASCULAR, INC.
    Product Code
    MIH
    PMA / PMN Number
    P120006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE BALLOON USED AT THE LEVEL OF THE PROXIMAL SEALING ZONE WAS PRESSURIZED MANUALLY TO AN UNKNOWN PRESSURE AND MAY HAVE RESULTED IN AN AORTIC PERFORATION, AS EVIDENCED BY THE EXTRAVASATION OF BLOOD FROM THE AORTA. THE PERFORATION OF THE AORTIC VESSEL MAY HAVE CONTRIBUTED TO THE SUBSEQUENT AORTIC RUPTURE, BUT THIS COULD NOT BE DEFINITIVELY CONCLUDED WITH THE LIMITED CASE IMAGING PROVIDED TO TRIVASCULAR.

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT ENDOVASCULAR REPAIR OF AAA WITH THE OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM ON (B)(6) 2013. THE PATIENT HAD AN ANGULATED AORTA (82 DEGREES) AT THE RENAL ARTERY WITH SIGNIFICANT CALCIUM PRESENT IN BOTH ILIAC VESSELS. THE AORTIC BODY AND BOTH ILIAC LIMB STENT GRAFTS WERE SUCCESSFULLY IMPLANTED. A TYPE IA ENDOLEAK WAS NOTED AT THE SEALING RINGS NEAR THE INNER CURVE, ADJACENT TO THE AORTIC ANGULATION, WHICH WAS PRESENT AFTER BALLOONING OF THE SEAL ZONE. A PALMAZ STENT WAS THEN ADVANCED TO THE SEAL ZONE UP TO THE PROXIMAL GRAFT COLLAR AND EXPANDED, DURING WHICH THE AORTA APPEARED TO BE BULGING. FOLLOWING STENT EXPANSION EXTRAVASATION OF BLOOD FROM THE VESSEL WAS OBSERVED ABOVE THE IMPLANTED PALMAZ STENT AND BELOW THE RENAL ARTERY. THE PROXIMAL SEAL ZONE WAS AGAIN BALLOONED FOR APPROXIMATELY 10 MINUTES. ALL BALLOON PRESSURIZATION WAS DONE MANUALLY USING A SYRINGE (UNKNOWN PRESSURE). AT THE COMPLETION OF THE CASE, THERE WAS NO EVIDENCE OF ENDOLEAK(S). ON (B)(6) 2013, A POST-OPERATIVE CT WAS PERFORMED THAT ALSO DEMONSTRATED SUCCESSFUL EXCLUSION OF THE ANEURYSM. LATER THAT DAY, THE PATIENT EXPERIENCED AN AORTIC RUPTURE AND EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    484798 OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM ENDOVASCULAR GRAFT, AORTIC ANEURYSM MIH TRIVASCULAR, INC. TV-AB3480-E FS041513-09

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Death