BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 3240379 · Received July 18, 2013

    Report

    Report Number
    3008011247-2013-00019
    Event Type
    Injury
    Date Received
    July 18, 2013
    Date of Event
    June 19, 2013
    Report Date
    June 19, 2013
    Manufacturer
    TRIVASCULAR, INC.
    Product Code
    MIH
    PMA / PMN Number
    P120006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE SUBJECT UNDERWENT ENDOVASCULAR REPAIR OF AAA USING THE OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM ON (B)(6) 2013. DURING THE ORIGINAL IMPLANT PROCEDURE, AND PRIOR TO POST DILATATION OF THE ILIAC LIMBS, THE 16F INTRODUCER SHEATH WAS INADVERTENTLY BACKED OUT OF THE ACCESS VESSEL ON THE CONTRA SIDE. THE PHYSICIAN DECIDED TO NOT RE-INTRODUCE THE 16F SHEATH AND TO FOREGO THE BALLOONING ON THE CONTRALATERAL SIDE. THE PT RETURNED FOR THE 30-DAY ROUTINE F/U AND THERE WAS EVIDENCE OF NARROWING OF THE LEFT (CONTRA) ILIAC LIMB; THERE WERE NO EVIDENCE OF ENDOLEAKS. THE SUBJECT RETURNED FOR A RE-INTERVENTION ON (B)(6) 2013, FOR A PLANNED PLACEMENT OF A STENT TO OPEN UP THE CONTRA LIMB. DURING THE RE-INTERVENTION, THE PHYSICIAN BELIEVED THAT STENTING WAS NO LONGER REQUIRED SINCE THE NARROWING OF THE LIMB WAS MINIMAL (LESS THAN 20%); THE PHYSICIAN DECIDED TO BALLOON THE LIMB SINCE ACCESS HAD ALREADY BEEN ACHIEVED. THE PHYSICIAN DOES NOT BELIEVE THAT THIS EVENT IS DEVICE RELATED, BUT RATHER PROCEDURE RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333458 OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM ENDOVASCULAR GRAFT, AORTIC ANEURYSM MIH TRIVASCULAR, INC. TV-AB3480-E FS092512-08

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention