BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANEURX

    MDR report key: 3211707 · Received July 8, 2013

    Report

    Report Number
    2953200-2013-01275
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    June 10, 2013
    Report Date
    June 10, 2013
    Manufacturer
    MEDTRONIC CARDIOVASCULAR SANTA ROSA
    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). METHOD: (FILMS). RESULTS: INHERENT RISK OF PROCEDURE (MIGRATION, ENDOLEAK); PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (ANATOMY RELATED ANGULATED NECK; DISEASE PROGRESSION). CONCLUSION: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (ANATOMY RELATED ANGULATED NECK; DISEASE PROGRESSION).

    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 IS UNKNOWN. DURING A FOLLOW UP VISIT IT WAS REPORTED THAT THE PATIENT'S AORTIC NECK ANGULATION WAS OVER 60 DEGREES AND THE BIFURCATED ANEURX STENT GRAFT HAD MIGRATED 20MM DISTALLY CAUSED BY DISEASE PROGRESSION. A TYPE IA ENDOLEAK WAS ALSO OBSERVED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE. A REVIEW OF RETURNED FILMS POST-IMPLANT CONFIRMED THAT THE STENT GRAFT WAS POSITIONED BELOW THE ANGULATED NECK, APPROXIMATELY 2CM BELOW THE RENAL ARTERIES, AND THERE WAS A PROXIMAL TYPE 1 ENDOLEAK. THE NECK WAS ANGULATED TO 90 DEGREES, AND MEASURED 25 X 31MM DIAMETER AT THE RENAL ARTERIES. IT IS LIKELY THE HIGHLY ANGULATED NECK CONTRIBUTED TO THE MIGRATION AND PROXIMAL TYPE I ENDOLEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311795 ANEURX SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR SANTA ROSA 1000444

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR