BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANEURX AAADVANTAGE STENT GRAFT SYSTEM

    MDR report key: 1032652 · Received April 22, 2008

    Report

    Report Number
    2953200-2008-00239
    Event Type
    Malfunction
    Date Received
    April 22, 2008
    Date of Event
    March 31, 2008
    Report Date
    March 31, 2008
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULT: LACK OF INFO (UNK CAUSE OF DISTAL STENT GRAFT MOVEMENT). CONCLUSION: LACK OF INFO (UNK CAUSE OF DISTAL STENT GRAFT MOVEMENT).

    Description of Event or Problem · 1

    AN ANEURX STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. ANEURYSM MORPHOLOGY WAS NOT REPORTED AND THE AORTIC NECK WAS 4 CM LONG. IT WAS REPORTED THE BIFURCATED STENT GRAFT WAS POSITIONED AT THE INTENDED LOCATION BELOW THE RENAL ARTERIES AND IT WAS DEPLOYED JUST BELOW THE RENAL ARTERIES UNTIL THE CONTRALATERAL GATE OPENED. THE CONTRALATERAL GATE AND RENAL ARTERIES WERE CONFIRMED WITH IVUS. THE ILIAC LIMB STENT GRAFT WAS IMPLANTED INTO THE CONTRALATERAL GATE, AND THEN DEPLOYMENT OF THE IPSILATERAL LIMB OF THE BIFURCATED STENT GRAFT WAS COMPLETED. UPON COMPLETION OF THE DEPLOYMENT AN ANGIOGRAM SHOWED THAT THE BIFURCATED STENT GRAFT HAD MOVED 1 CM DISTALLY; HOWEVER, IT IS UNK WHAT CAUSED THE STENT GRAFT MOVEMENT. SINCE THE AORTIC NECK WAS 4 CM LONG THERE WAS ENOUGH OVERLAP WITH THE STENT GRAFT; THEREFORE, THE PHYSICIAN DECIDED NO FURTHER INTERVENTION WAS NECESSARY. THERE WAS A GOOD OUTCOME OF THE PROCEDURE. NO ADD'L CLINICAL SEQUELAE WERE REPORTED AND THE PT IS FINE. THE DELIVERY SYSTEM WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANEURX AAADVANTAGE STENT GRAFT SYSTEM MIH MEDTRONIC CARDIOVASCULAR NA V00075384

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR