BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANEURX AAADVANTAGE STENT GRAFT SYSTEM - HYRDO

    MDR report key: 1933751 · Received December 16, 2010

    Report

    Report Number
    2953200-2010-02559
    Event Type
    Injury
    Date Received
    December 16, 2010
    Date of Event
    November 16, 2010
    Report Date
    November 16, 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
    NV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION: RESULTS: (ARTERIAL TRAUMA/DISSECTION/PERFORATION), (SMALL IN DIAMETER STENOTIC AORTA), AND (DEVICE WAS USED IN A PT WITH INADEQUATE ANATOMY). CONCLUSIONS: (SMALL IN DIAMETER STENOTIC AORTA), AND (DEVICE WAS USED IN A PT WITH INADEQUATE ANATOMY).

    Description of Event or Problem · 1

    AN ANEURX STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF A STENOTIC AND CALCIFIED ABDOMINAL AORTA 1 MONTH AGO. THE AORTA WAS AS NARROW AS 3 MM IN DIAMETER. THE RIGHT KIDNEY WAS NON-FUNCTIONAL PRIOR TO THE EVAR, AND THE LEFT KIDNEY HAD A RENAL STENT. IT WAS REPORTED THAT AFTER USING A CUTTING BALLOON, AN ANEURX LIMB WAS IMPLANTED TO TREAT THE STENOTIC AORTA. AFTER THE ANGIO RUN, AN AORTIC PERFORATION WAS DIAGNOSED, AS EXTRAVASATION WAS NOTED INTO THE SOFT TISSUE OUTSIDE THE AORTA NEAR THE RENALS. ANOTHER ANEURX LIMB WAS PLACED IN AN ATTEMPT TO SEAL THE PERFORATION; HOWEVER, THERE WAS STILL EXTRAVASATION (SEE MFR# 2953200-2010-02560). IT WAS DECIDED TO PERFORM AN OPEN REPAIR AND AN AORTO-BI-FEMORAL BYPASS. THE GRAFTS WERE EXPLANTED, AND A TUBE GRAFT SEWN IN. THERE HAD BEEN NO COVERAGE OF THE RENALS BY THE ANEURX GRAFTS OR TUBE GRAFT. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANEURX AAADVANTAGE STENT GRAFT SYSTEM - HYRDO MIH MEDTRONIC CARDIOVASCULAR GALWAY NA V00540632

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention