BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANEURX AAADVANTAGE STENT GRAFT SYSTEM - HYDRO

    MDR report key: 1488306 · Received September 30, 2009

    Report

    Report Number
    2953200-2009-01354
    Event Type
    Injury
    Date Received
    September 30, 2009
    Date of Event
    September 1, 2009
    Report Date
    September 1, 2009
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    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

    EVALUATION: RESULTS: ARTERIAL TRAUMA/DISSECTION/PERFORATION, BALLOON. CONCLUSIONS: BALLOON.

    Description of Event or Problem · 1

    AN ANEURX STENT GRAFT WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. ANEURYSM AND VESSEL MORPHOLOGY WERE NOT REPORTED. IT WAS REPORTED THAT THE BIFURCATED STENT GRAFT AND THE CONTRALATERAL LIMB WERE SUCCESSFULLY IMPLANTED. WHILE THE PHYSICIAN WAS BALLOONING THE PROXIMAL END OF THE STENT GRAFT WITH A RELIANT BALLOON (MFR# 2053200-200-1355), THE AORTA WAS RUPTURED AT THE LEVEL OF THE LOWEST RENAL ARTERY (THE RIGHT RENAL ARTERY) BY OVER-INFLATING THE BALLOON OUTSIDE THE STENT GRAFT. BALLOONING WAS PERFORMED WITH A 30 CC SYRINGE WITH 30% CONTRAST 70% SALINE SOLUTION; HOWEVER, IT IS UNK HOW MUCH SOLUTION WAS INJECTED. IT WAS NOTED THAT THE PHYSICIAN INFLATED THE BALLOON QUICKLY WITHOUT CONFIRMING ITS POSITION. THE BALLOON WAS DEFLATED, AND THE PHYSICIAN HAD CONTINUED TO BALLOON THE STENT GRAFT DISTALLY WITHOUT REALIZING THAT THE AORTA WAS RUPTURED. IT WAS NOTED THAT THE PT'S BLOOD PRESSURE WAS DROPPING, AND AN ANGIOGRAM SHOWED EXTRAVASATION IN THE AORTA. THE PHYSICIAN ELECTED TO USE A SECOND RELIANT BALLOON, WHICH WAS INFLATED AT THE LEVEL OF THE CELIAC ARTERY TO CONTROL THE BLOODING; HOWEVER, THE BLOOD PRESSURE KEPT PUSHING THE BALLOON DISTALLY APPROX 1 CM WITH EACH SYSTOLIC BEAT. THE PHYSICIAN THEN ELECTED TO PERFORM AN OPEN CONVERSION. THE STENT GRAFT WAS LEFT IN PLACE, AND A DACRON GRAFT WAS USED TO PATCH THE DISSECTED AREA OF THE AORTA. THE PT LOST SIGNIFICANT AMOUNTS OF BLOOD AND WAS GIVEN OVER 15 UNITS OF BLOOD. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED, AND THE PT IS FINE. THE ANEURX AND RELIANT DELIVERY CATHETERS WERE DISCARDED AFTER THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANEURX AAADVANTAGE STENT GRAFT SYSTEM - HYDRO MIH MEDTRONIC CARDIOVASCULAR GALWAY NA V00344283

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention