BEUDAMED
    FDA Adverse Event Other Summary report: N

    OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 3593333 · Received January 8, 2014

    Report

    Report Number
    3008011247-2014-00004
    Event Type
    Other
    Date Received
    January 8, 2014
    Date of Event
    December 13, 2013
    Report Date
    January 20, 2015
    Manufacturer
    TRIVASCULAR, INC.
    Product Code
    MIH
    PMA / PMN Number
    P120006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON FOLLOW-UP INFORMATION RECEIVED FROM THE DISTRIBUTOR ON JANUARY 20, 2015, THE PATIENT RETURNED FOR A RE-INTERVENTION ON (B)(6) 2013 WHERE AN AORTIC CUFF WAS PLACED WITHIN THE AORTIC BODY SEALING RINGS AND SUCCESSFULLY RESOLVED THE TYPE IA ENDOLEAK. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL IN (B)(6) 2014 WITH NO ADDITIONAL PATIENT SEQUELAE REPORTED. FOLLOWING THE RE-INTERVENTION PROCEDURE IN (B)(6) 2013, THERE HAVE BEEN THREE (3) FOLLOW-UP CT'S PERFORMED IN 3-4 MONTHS INTERVALS, ALL OF WHICH CONTINUE TO SHOW EXCLUSION OF THE ANEURYSM.

    Description of Event or Problem · 1

    THE PT UNDERWENT ENDOVASCULAR REPAIR OF (B)(4) WITH THE OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM ON (B)(6) 2013. THE STENT GRAFT SYSTEM WAS IMPLANTED AND THE AORTIC BODY AND ILIAC LIMBS WERE BALLOONED. UPON FINAL ANGIOGRAM, THE AORTIC BODY WAS OBSERVED TO BE APPROX 1CM DISTAL TO THE INTENDED LANDING SITE, RESULTING IN A TYPE IA ENDOLEAK. BASED ON COMMUNICATION FROM THE CASE SUPPORTER, THE STIFF GUIDEWIRE WAS NOT RETRACTED DURING FILL WHICH CAN LEAD TO POOR APPOSITION OF THE SEAL RINGS TO THE VESSEL WALL. THE PHYSICIAN BELIEVED THE ENDOLEAK WAS SMALL AND THAT IT MIGHT RESOLVE ITSELF. A FOLLOW-UP CT WAS PLANED FOR (B)(6) 2013 TO DETERMINE IF A RE-INTERVENTION WOULD BE REQUIRED. AS OF THE DATE OF THIS REPORT, THERE HAS BEEN NO CONFIRMATION THAT A CT SCAN OR REINTERVENTION WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    14509 OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM ENDOVASCULAR GRAFT, AORTIC ANEURYSM MIH TRIVASCULAR, INC. TV-AB3480-D FS051512-16

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Other| R GORE AORTIC CUFF