BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANEURX STENT GRAFT SYSTEM

    MDR report key: 2761146 · Received September 26, 2012

    Report

    Report Number
    2953200-2012-01858
    Event Type
    Injury
    Date Received
    September 26, 2012
    Date of Event
    August 30, 2012
    Report Date
    August 30, 2012
    Manufacturer
    MEDTRONIC CARDIOVASCULAR SANTA ROSA
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: INHERENT RISK OF PROCEDURE (MIGRATION). PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (DISEASE PROGRESSION; NECK DILATATION). CONCLUSION: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (DISEASE PROGRESSION; NECK DILATATION).

    Description of Event or Problem · 1

    AN ANEURX STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM APPROXIMATELY 6 YEARS AGO. ANEURYSM AND VESSEL MORPHOLOGY FROM THE TIME OF IMPLANT WERE NOT REPORTED. IT WAS REPORTED THAT DURING A ROUTINE FOLLOW-UP THE STENT GRAFT WAS FOUND TO HAVE MIGRATED DISTALLY 2 CM. THE STENT GRAFT MIGRATION WAS ATTRIBUTED TO DISEASE PROGRESSION AND AORTIC NECK DILATATION TO 23 - 25 MM IN DIAMETER. AN ANEURX 28 MM DIAMETER AORTIC CUFF WAS IMPLANTED TO SUCCESSFULLY ADDRESS THE STENT GRAFT MIGRATION. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANEURX STENT GRAFT SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR SANTA ROSA 828667

    Patients

    Seq Age Sex Outcome Treatment
    1 00081 YR Required Intervention