BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANEURX STENT GRAFT SYSTEM

    MDR report key: 2832671 · Received November 14, 2012

    Report

    Report Number
    2953200-2012-02185
    Event Type
    Injury
    Date Received
    November 14, 2012
    Date of Event
    October 23, 2012
    Report Date
    October 23, 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. ANEURYSM AND VESSEL MORPHOLOGY AT THE TIME OF IMPLANT WERE NOT REPORTED. CURRENTLY THERE IS DISEASE PROGRESSION WITH AORTIC NECK DILATION. THE AORTIC NECK HAD DILATED MEASURING 28 MM FOR ABOUT 1 CM AND 29 MM FOR THE NEXT 1 CM. IT WAS REPORTED THAT A RECENT DISCOVERED THE BIFURCATED STENT GRAFT HAS MIGRATED 2 CM DISTALLY BELOW THE LOWEST RENAL. THERE WAS NO EVIDENCE OF AN ENDOLEAK. THE PHYSICIAN SUCCESSFULLY TREATED THE MIGRATION OF THE BIFURCATED STENT GRAFT WITH THE IMPLANTATION OF AN ENDURANT AORTIC CUFF. 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 V00034987

    Patients

    Seq Age Sex Outcome Treatment
    1 00073 YR Required Intervention