BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC ANEURX

    MDR report key: 3971755 · Received July 31, 2014

    Report

    Report Number
    2953200-2014-01494
    Event Type
    Injury
    Date Received
    July 31, 2014
    Date of Event
    July 7, 2014
    Report Date
    March 10, 2015
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    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 IS UNKNOWN. IT WAS REPORTED THAT THE PATIENT HAD BEEN COMPLIANT WITH FOLLOW UP OVER THE LAST 11 YEARS WITH NO ANEURYSM ENLARGEMENT. ON A CURRENT FOLLOW UP IT WAS NOTED THAT THE ANEURYSM HAD GONE FROM 4.0 TO 5.5 CM IN DIAMETER. THE PHYSICIAN COULD NOT DETERMINE IF THE ANEURYSM ENLARGEMENT WAS FROM A TYPE II ENDOLEAK OR A TYPE III ENDOLEAK, FABRIC. THE PHYSICIAN RELINED THE MAIN BODY. THE PHYSICIAN WAS UNABLE TO DETERMINE THE CAUSE OF THE EVENT FROM THE FILMS. THE PATIENT WILL BE MONITORED BY THE PHYSICIAN. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Description of Event or Problem · 1

    THE PATIENT IS DOING WELL AND THE ENDOLEAK HAS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448932 MEDTRONIC ANEURX SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR M02L550048

    Patients

    Seq Age Sex Outcome Treatment
    1 00086 YR Required Intervention