BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANEURX AAADVANTAGE STENT GRAFT HYDRO

    MDR report key: 1250645 · Received December 3, 2008

    Report

    Report Number
    2953200-2008-01114
    Event Type
    Injury
    Date Received
    December 3, 2008
    Date of Event
    November 3, 2008
    Report Date
    November 3, 2008
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: RESULTS AND CONCLUSION: ARTERIAL TRAUMA/DISSECTION/PERFORATION. FIVE MM TO 6MM IN DIAMETER IN THE ILIAC ARTERIES, FRAIL AND MODERATE CALCIFICATION OF THE VESSELS). SECONDARY INTERVENTION REQUIRED.

    Description of Event or Problem · 1

    AN ANEURX STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. ANEURYSM MORPHOLOGY WAS NOT REPORTED. THE VESSELS WERE 5MM TO 6MM IN DIAMETER IN THE ILIAC ARTERIES, FRAIL AND MODERATE CALCIFICATION OF THE VESSELS. IT WAS REPORTED THAT THE PATIENT WAS NOT AN OPEN SURGICAL REPAIR CANDIDATE. THE PHYSICIAN ATTEMPTED TO ADVANCE THE DEVICE UP TO THE RIGHT SIDE HOWEVER WAS UNABLE TO REACH THE INTENDED LESION SITE AND THE DELIVERY CATHETER WAS REMOVED WITHOUT ISSUE. THE PHYSICIAN THEN ADVANCED THE SAME STENT GRAFT UP THE LEFT SIDE SUCCESSFULLY IMPLANTING THE DEVICE. THE PHYSICIAN NOTICED THAT ON THE RIGHT SIDE THERE WAS EXTRAVASATION OF CONTRAST. THE PHYSICIAN REPAIRED THE DISSECTION WITH ANOTHER MANUFACTURER'S COVERED STENT. THERE WAS NO BLOOD FLOW THROUGH THE LEFT FEMORAL ARTERY, DUE TO A TEAR/DISSECTION WHICH WAS REPAIRED WITH A BOVINE PERICARDIAL PATCH. THE DELIVERY CATHETER WAS DISCARDED BY THE USER FACILITY. NO CLINICAL SEQUELA WERE REPORTED AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANEURX AAADVANTAGE STENT GRAFT HYDRO MIH MEDTRONIC CARDIOVASCULAR NA V00204629

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention