BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANEURX AAADVANTAGE STENT GRAFT SYSTEM

    MDR report key: 2190816 · Received July 8, 2011

    Report

    Report Number
    2953200-2011-01259
    Event Type
    Injury
    Date Received
    July 8, 2011
    Date of Event
    June 6, 2011
    Report Date
    June 8, 2011
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION, RESULTS: (ENDOLEAK, MIGRATION); (DISEASE PROGRESSION; ANGULATED NECK); (AORTIC NECK ANGULATED AT GREATER THAN 90 DEGREES). CONCLUSION: (DISEASE PROGRESSION; ANGULATED NECK); (AORTIC NECK ANGULATED AT GREATER THAN 90 DEGREES).

    Description of Event or Problem · 1

    AN ANEURX BIFURCATED STENT GRAFT (REF MFR 2953200-2011-01259) WAS IMPLANTED FOR ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM APPROX FIVE YEARS AGO. THE PT HAS BEEN VERY COMPLIANT WITH FOLLOW-UPS; A SONOGRAM APPROX 15 MONTHS AGO SHOWED NO PROBLEMS. A ROUTINE CT IN ONE MONTH AGO SHOWED THAT THE STENT GRAFT HAD MIGRATED DISTALLY WITH A PROXIMAL TYPE I ENDOLEAK DUE TO DISEASE PROGRESSION. THE TOP OF THE STENT GRAFT IS AT THE TOP OF THE AAA, ABOUT 2.5-3 CM BELOW THE RENAL ARTERIES. CURRENTLY, THE AAA IS 9.7 CM IN DIAMETER, AND THE AORTIC NECK IS 15-17 MM IN DIAMETER, 2.5-3 CM LONG, AND ANGULATED AT GREATER THAN 90 DEGREES. THE MIGRATION WAS ATTRIBUTED TO THE AORTIC NECK ANGULATION. AN INTERVENTION WAS PERFORMED 3 WEEKS AGO. THERE WAS ONLY ROOM TO PLACE ONE ENDURANT CUFF (REF MFR 2953200-2011-01260), WHICH WAS PLACED RIGHT AT THE RENALS. THE CUFF WAS BALLOONED MULTIPLE TIMES WITH A RELIANT BALLOON, BUT THERE WAS A VERY SMALL PROXIMAL TYPE I ENDOLEAK, THAT IS EXPECTED TO SELF-RESOLVE. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED, THE PT IS FINE, AND WILL BE MONITORED. AN INTERNAL REVIEW OF FILMS PRIOR TO THE TIME OF THE ENDURANT CUFF PLACEMENT SHOWS A HIGHLY ANGULATED NECK (>90DEG) WITH A PROXIMAL TYPE I ENDOLEAK AND A DISTAL MIGRATION OF THE ANEURX STENT GRAFT TO AT OR JUST BELOW THE AORTIC NECK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANEURX AAADVANTAGE STENT GRAFT SYSTEM MIH MEDTRONIC CARDIOVASCULAR NA A83741

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Required Intervention