BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANEURX AAADVANTAGE STENT GRAFT SYSTEM - HYDRO

    MDR report key: 1841219 · Received September 10, 2010

    Report

    Report Number
    2953200-2010-01723
    Event Type
    Injury
    Date Received
    September 10, 2010
    Date of Event
    August 5, 2010
    Report Date
    August 11, 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
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION, RESULTS: (ARTERIAL AND VENOUS OCCLUSION); (NARROW AORTIC NECK). CONCLUSIONS: (NARROW AORTIC NECK).

    Description of Event or Problem · 1

    AN ANEURX STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF A 5 CM ABDOMINAL AORTIC ANEURYSM APPROX 2 MONTHS AGO. THE AORTIC NECK WAS 12-14 MM LONG AND 18-20 MM IN DIAMETER. THE VESSELS WERE SMALL. THE PT HAD A RIGHT ACCESSORY RENAL ARTERY THAT WAS COVERED WITH THE STENT GRAFT; HOWEVER, THERE WAS STILL PERFUSION. THE CT SCAN REPORT NOTED A RIGHT RENAL ARTERY INFARCTION AND NO ENDOLEAKS WERE REPORTED. NO INTERVENTION WAS PERFORMED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PT 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 V00418689

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention