BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANEURX

    MDR report key: 3232500 · Received July 18, 2013

    Report

    Report Number
    2953200-2013-01380
    Event Type
    Injury
    Date Received
    July 18, 2013
    Date of Event
    January 1, 2013
    Report Date
    June 24, 2013
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION, RESULTS: INHERENT RISK OF PROCEDURE (ENDOLEAK); OTHER (LACK OF INFORMATION, UNKNOWN CAUSE OF ENDOLEAK). CONCLUSION: (LACK OF INFORMATION, UNKNOWN CAUSE OF ENDOLEAK); KNOWN INHERENT RISK OF A PROCEDURE (ENDOLEAK).

    Description of Event or Problem · 1

    AN ANEURX STENT GRAFT SYSTEM WAS IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. ANEURYSM AND VESSEL MORPHOLOGY AT THE TIME OF IMPLANT ARE UNKNOWN. IT WAS REPORTED THAT THE PATIENT CALLED TO REPORT THAT THERE WAS AN ENDOLEAK AND THAT THE ABDOMINAL AORTIC ANEURYSM WAS GROWING, MORE SPECIFICALLY FROM 5.5 TO 5.7CM. THE PATIENT WASN'T SPECIFIC AS TO IF IT WAS DIRECTLY FROM THE GRAFT ITSELF BUT FROM THE DESCRIPTION SOUNDED LIKE IT WAS LOCATED IN AN AREA NOT CURRENTLY COVERED BY THE EXISTING STENT GRAFTS. THE PATIENT HAS BEEN GETTING RECOMMENDED IMAGING CHECK-UPS AND STATED THAT THEY WERE NOT EXPERIENCING ANY DISCOMFORT OR CHANGE TO ACTIVITIES OF DAILY LIVING. NO CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    336014 ANEURX SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR 667890

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR