BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANEURX AAADVANTAGE STENT GRAFT SYSTEM-HYDRO

    MDR report key: 1760623 · Received July 14, 2010

    Report

    Report Number
    2953200-2010-01307
    Event Type
    Injury
    Date Received
    July 14, 2010
    Date of Event
    June 14, 2010
    Report Date
    June 14, 2010
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): EVALUATION RESULTS: (ENDOLEAK), (REVERSE-FUNNEL SHAPED AORTIC NECK).

    Description of Event or Problem · 1

    AN ANEURX STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR ENDOVASCULAR TREATMENT OF A 5 CM ABDOMINAL AORTIC ANEURYSM APPROXIMATELY 48 MONTHS AGO. VESSEL MORPHOLOGY AT THE TIME OF IMPLANT WAS NOT REPORTED. IT WAS REPORTED THAT THE PATIENT PRESENTED SYMPTOMATICALLY APPROXIMATELY 1 MONTH AGO, AND THE CT DEMONSTRATED THAT THE BIFURCATED STENT GRAFT (MFR REPORT # 2953200-2010-01306) HAD MIGRATED 10 MM DISTALLY, RESULTING IN A PROXIMAL TYPE I ENDOLEAK. AT THE TIME OF MIGRATION, THE ANEURYSM WAS 8 CM IN DIAMETER, AND THE VESSEL MORPHOLOGY WAS REPORTED AS MILD TORTUOSITY AND MILD CALCIFICATION. THE AORTIC NECK WAS 23 MM IN LENGTH, REVERSE-FUNNEL SHAPED AND RANGED IN DIAMETER FROM 22 MM TO 30 MM DISTALLY, AND HAD ANGULATION OF 20 DEGREES. THE CAUSE OF THE MIGRATION WAS ATTRIBUTED TO DISEASE PROGRESSION WITH AORTIC NECK DILATION. THE PHYSICIAN ELECTED TO INTERVENE FOR THE ENDOLEAK AND MIGRATION WITH ANEURX AORTIC CUFF HOWEVER, THE AORTIC CUFF WAS PLACED LOWER THAN INTENDED, AND THERE WAS STILL A TYPE I ENDOLEAK. THE PHYSICIAN THEN PLACED A 30 MM TALENT AORTIC CUFF, WHICH SUCCESSFULLY RESOLVED THE TYPE I ENDOLEAK. NO ADDITIONAL CLINICAL SEQUELAE REPORTED, AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANEURX AAADVANTAGE STENT GRAFT SYSTEM-HYDRO MIH MEDTRONIC CARDIOVASCULAR GALWAY NA V00307813

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention