BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V12

    MDR report key: 3240157 · Received July 18, 2013

    Report

    Report Number
    1219977-2013-00093
    Event Type
    Injury
    Date Received
    July 18, 2013
    Date of Event
    June 21, 2013
    Report Date
    June 22, 2013
    Manufacturer
    ATRIUM MEDICAL CORP.
    Product Code
    DYF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AWAITING THE RETURN OF THE DEVICE FOR EVALUATION. UPON COMPLETION OF THE EVALUATION A FOLLOW-UP WILL BE SUBMITTED. REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND THE DEVICE WAS FOUND TO HAVE MET ALL SPECIFICATIONS WITHOUT ANY DEVIATIONS.

    Description of Event or Problem · 1

    PT CAME IN WITH A LARGE ABDOMINAL AORTIC ANEURYSM. FENESTRATED AORTIC STENT GRAFT PROCEDURE WAS PERFORMED WITH FENESTRATION FOR (R) RENAL AND SMA WITH CHIMNEY STENT FOR (L) RENAL ARTERY. FOR THESE VESSELS ATRIUM GRAFT STENTS WERE PLACED. FOLLOWING THE PROCEDURE, FINAL CHECK ANGIOGRAM REVEALED TYPE 1 ENDOLEAK FROM (L) RENAL ARTERY ATRIUM STENT GRAFT. THIS WAS DUE TO A PIN-HOLE DEFECT IN THE GRAFT. TO SEAL THIS DEFECT ANOTHER SMALLER LENGTH GRAFT WAS DEPLOYED, THE LEAK STOPPED AND THE PROCEDURE WAS SUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333784 V12 PTFE COVERED STENT DYF ATRIUM MEDICAL CORP. 85337 10841061

    Patients

    Seq Age Sex Outcome Treatment
    1 Other SHEATH - CORDIS 8FR X 90CM| GUIDE WIRE - ROSEN 0.035 X 260CM