BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANEURX AAADVANTAGE STENT GRAFT SYSTEM - HYDRO

    MDR report key: 1841642 · Received September 16, 2010

    Report

    Report Number
    2953200-2010-01761
    Event Type
    Injury
    Date Received
    September 16, 2010
    Date of Event
    August 17, 2010
    Report Date
    August 17, 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
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION, RESULTS: (ENDOLEAK), (ANGULATED AORTIC NECK AND TORTUOUS ILIAC ARTERIES). CONCLUSIONS: (ANGULATED AORTIC NECK AND TORTUOUS ILIAC ARTERIES).

    Description of Event or Problem · 1

    AN ANEURX STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 5.9 CM ABDOMINAL AORTIC ANEURYSM APPROXIMATELY ONE MONTH AGO. THE ILIAC VESSELS WERE TORTUOUS AND CALCIFIED. THE AORTIC NECK IS GREATER THAN 30 MM IN LENGTH, MODERATELY ANGULATED, HAD MILD CALCIFICATION, AND 25 MM IN DIAMETER PROXIMALLY AND 27 MM IN DIAMETER DISTALLY. IT WAS REPORTED THAT AFTER BALLOONING THE STENT GRAFTS, A POST-ANGIOGRAM DEMONSTRATED A PROXIMAL TYPE I ENDOLEAK (MFR REPORT # 2953200-2010-01761). IT APPEARED THAT THE NECK ANGULATION WAS PREVENTING SEAL ON THE RIGHT SIDE, AS THE GRAFT SAT 1 CM BELOW THE RIGHT RENAL ARTERY; CONTRAST COULD BE SEEN BEYOND THE GRAFT AT THAT LOCATION. AS APPROXIMATELY 3-5 MM WERE AVAILABLE BELOW THE LEFT RENAL, THE PHYSICIAN DECIDED TO PLACE AN AORTIC CUFF FROM THE LEFT SIDE TO BETTER MATCH THE ANGLE OF THE AORTA. HOWEVER, ACCURATE PLACEMENT WAS DIFFICULT DUE TO THE TORTUOUS ILIAC ARTERIES, AND CONSEQUENTLY, THE LEFT RENAL ARTERY WAS ENCROACHED UPON BY THE AORTIC CUFF (MFR REPORT # 2953200-2010-01762). ATTEMPTS TO STENT THE LEFT RENAL ARTERY WERE UNSUCCESSFUL, AND THE PHYSICIAN ELECTED NOT TO INTERVENE ANY FURTHER. THE LEFT RENAL ARTERY WAS FILLING ON THE ANGIOGRAM, AND THE PROXIMAL TYPE I ENDOLEAK HAD RESOLVED. NO ADDITIONAL CLINICAL SEQUELAE WERE 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 V00500811

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention