BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 3240312 · Received July 18, 2013

    Report

    Report Number
    3008011247-2013-00018
    Event Type
    Injury
    Date Received
    July 18, 2013
    Date of Event
    January 1, 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
    FI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PATIENT UNDERWENT ENDOVASCULAR REPAIR OF AAA USING THE OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM ON (B)(6) 2013. THE PHYSICIAN HAD OBSERVED AN INFOLDING OF THE PROXIMAL RING DURING AN 8 WEEK POST-OP CT SCAN PERFORMED ON (B)(6) 2013. NO ENDOLEAK WAS DETECTED AT THAT TIME. FOLLOW UP INFORMATION WAS RECEIVED BY TRIVASCULAR ON (B)(6) 2013 STATING THAT THE PATIENT UNDERWENT A RE-INTERVENTION ON AN UNKNOWN DATE TO PLACE A BALLOON EXPANDABLE STENT AT THE LOCATION OF AN INFOLD IN THE SEALING RINGS OF THE AORTIC BODY GRAFT WITH A GOOD RESULT. THE ROOT CAUSE OF THE LUMINAL DIAMETER REDUCTION REQUIRING SUBSEQUENT RE-INTERVENTION WAS CONFIRMED TO BE A RESULT OF A SLIGHT INFOLD IN THE AORTIC BODY GRAFT SEALING RINGS. THE CAUSE OF THE GRAFT INFOLD IN THE SEALING RINGS COULD NOT BE DETERMINED; A 34 MM GRAFT WAS IMPLANTED WHICH IS CONSISTENT WITH THE SIZE RECOMMENDED IN THE PRE-CASE SIZING AND PLANNING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333290 OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM ENDOVASCULAR GRAFT, AORTIC ANEURYSM MIH TRIVASCULAR, INC. TV-AB3480-D FS051612-28

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention