BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 3796662 · Received May 7, 2014

    Report

    Report Number
    3008011247-2014-00022
    Event Type
    Injury
    Date Received
    May 7, 2014
    Date of Event
    March 31, 2014
    Report Date
    March 31, 2014
    Manufacturer
    TRIVASCULAR, INC.
    Product Code
    MIH
    PMA / PMN Number
    P120006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT ENDOVASCULAR REPAIR OF AAA WITH THE OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM ON (B)(6) 2014. THE ACCESS VESSELS WERE SMALL AND HAD SIGNIFICANT CALCIFICATION. THE ILIAC VESSELS WERE BALLOONED AND SELF-EXPANDING STENTS WERE DEPLOYED IN THE COMMON ILIAC ARTERIES. AFTER DILATION OF THE ILIAC ARTERIES, THE PHYSICIAN WAS ABLE TO ADVANCE AND DEPLOY THE AORTIC BODY AND ILIAC LIMBS SUCCESSFULLY. UPON FINAL ANGIO A TYPE IA ENDOLEAK WAS OBSERVED, WHICH BALLOONING DID NOT RESOLVE. THE PHYSICIAN PLANNED TO BRING THE PATIENT BACK IN ONE MONTH TO EVALUATE THE ENDOLEAK AND THE NEED FOR A RE-INTERVENTION. AS OF THE ONE MONTH FOLLOW-UP, THE ENDOLEAK PERSISTS AND THERE HAS BEEN NO RE-INTERVENTION FOR THIS PATIENT. BASED ON THE PRE-CASE CT FOR THIS PATIENT, THE AORTIC DIAMETER AND THE VESSEL ANGULATION WERE OUTSIDE THE IFU TREATMENT SPECIFICATION. THE PHYSICIAN HAD ELECTED TO TREAT THE PATIENT WITH THE DEVICE SINCE THE PATIENT HAD LIMITED OPTIONS GIVEN THE PATIENT'S ACCESS VESSELS. THE CAUSE OF THE ENDOLEAK IS THEREFORE IMPLANTATION OF A GRAFT THAT WAS NOT APPROPRIATE FOR THE PATIENT'S ANATOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273442 OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM ENDOVASCULAR GRAFT, AORTIC ANEURYSM MIH TRIVASCULAR, INC. TV-AB3480-E FS073013-40

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other