BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANEURX ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 2892510 · Received January 2, 2013

    Report

    Report Number
    2953200-2012-02549
    Event Type
    Injury
    Date Received
    January 2, 2013
    Date of Event
    December 4, 2012
    Report Date
    December 4, 2012
    Manufacturer
    MEDTRONIC CARDIOVASCULAR SANTA ROSA
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: INHERENT RISK OF PROCEDURE (MIGRATION, ENDOLEAK); PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (DISEASE PROGRESSION). CONCLUSION: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (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 APPROXIMATELY 10.5 YEARS AGO. ANEURYSM AND VESSEL MORPHOLOGY FROM THE TIME OF IMPLANT WERE NOT REPORTED. IT WAS REPORTED THAT DURING A ROUTINE FOLLOW UP THAT THE PATIENT WAS FOUND TO HAVE A LARGE AAA SAC, MEASURING 8.7 X 7.6 WITH A PROMINENT DISTAL TYPE IB ENDOLEAK PRESENT. THERE APPEARS TO BE LOSS OF SEAL AT THE RIGHT ILIAC LIMB; HOWEVER, IT IS UNKNOWN IF THE ENDOLEAK WAS FROM THE IPSILATERAL LIMB OF THE BIFURCATED STENT GRAFT OR FROM THE ILIAC LIMB ON THE CONTRALATERAL SIDE. THE BIFURCATED STENT GRAFT WAS APPROXIMATELY 12-15 MM BELOW THE RENAL ARTERIES; HOWEVER, THERE DOES NOT APPEAR TO BE A PROXIMAL TYPE I ENDOLEAK. THE PHYSICIAN IMPLANTED AN ILIAC STENT GRAFT EXTENSION IN EACH ILIAC ARTERY AND SUCCESSFULLY RESOLVED THE ENDOLEAK. THE STENT GRAFT MIGRATION WAS NOT ADDRESSED AS THERE WAS NOT ENOUGH ROOM TO PLACE AN AORTIC CUFF. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED, AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1168 ANEURX ABDOMINAL STENT GRAFT SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR SANTA ROSA M02E552800

    Patients

    Seq Age Sex Outcome Treatment
    1 00081 YR Required Intervention