BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANEURX ADVANTAGE BIFURCATED STENT GRAFT - HYDRO

    MDR report key: 3083453 · Received April 29, 2013

    Report

    Report Number
    2953200-2013-00806
    Event Type
    Injury
    Date Received
    April 29, 2013
    Date of Event
    April 4, 2013
    Report Date
    April 4, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: INHERENT RISK OF PROCEDURE (MIGRATION) ; PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (DISEASE PROGRESSION; AORTIC NECK DILATATION). CONCLUSION: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (DISEASE PROGRESSION; AORTIC 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 IS UNKNOWN. CURRENTLY THE VESSEL MORPHOLOGY WAS REPORTED AS THE AORTIC NECK WAS 30 MM IN DIAMETER AT THE RENAL ARTERIES. THERE IS DISEASE PROGRESSION WITH AORTIC NECK DILATATION. A RECENT CT AND ANGIOGRAM REVEALED THAT THE STENT GRAFT HAS MIGRATED DISTALLY 2 CM, THERE IS NO TYPE I ENDOLEAK BUT THERE IS A TYPE II ENDOLEAK COMING FROM A LUMBAR ARTERY. THE PHYSICIAN ELECTED TO IMPLANT A 36X36X49 ENDURANT AORTIC CUFF AND THE MIGRATION WAS RESOLVED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183813 ANEURX ADVANTAGE BIFURCATED STENT GRAFT - HYDRO SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V00342141

    Patients

    Seq Age Sex Outcome Treatment
    1 00073 YR