BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANEURX AAADVANTAGE STENT GRAFT SYSTEM - HYDRO

    MDR report key: 1518200 · Received October 28, 2009

    Report

    Report Number
    2953200-2009-01495
    Event Type
    Injury
    Date Received
    October 28, 2009
    Date of Event
    October 2, 2009
    Report Date
    October 2, 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
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: RESULTS: ARTERIAL AND VENOUS OCCLUSION. DID NOT SLOWLY DEPLOY THE GRAFT BY ROTATING THE HANDLE. CONCLUSION: DID NOT SLOWLY DEPLOY THE GRAFT BY ROTATING THE HANDLE.

    Description of Event or Problem · 1

    AN ANEURX STENT GRAFT SYSTEM WAS IMPLANTED APPROX 31 MONTHS AGO, IN A PT AND PLACED INSIDE A DACRON TUBE GRAFT THAT WAS PREVIOUSLY IMPLANTED FOR AN OPEN REPAIR OF AN ILIAC AORTIC ANEURYSM. ANEURYSM AND VESSEL MORPHOLOGY WERE NOT REPORTED. IT WAS REPORTED THAT A CT SCAN OBTAINED APPROX 1 MONTH AGO, SHOWED THAT ANEURX STENT GRAFT HAD MIGRATED 2 CM WITH THE PRESENCE OF A PROXIMAL TYPE I ENDOLEAK (MFR # 2953200-2009-00229-1). THE AORTIC NECK HAD DILATED TO 28 MM OR 29 MM WITH AN ANGULATION OF 35 DEGREES. THERE WAS ILIAC FIXATION TO THE HYPOGASTRIC ARTERIES BILATERALLY. THE PHYSICIAN ELECTED TO TREAT THE MIGRATION WITH AN ANEURX CUFF AND A TALENT CUFF. IT WAS REPORTED THAT WHEN DEPLOYING THE ANEURX CUFF, THE PHYSICIAN PULLED THE TRIGGER ON THE DELIVERY SYSTEM AS SOON AS THE STENT GRAFT WAS POSITIONED, RATHER THAN SLOWLY DEPLOYING THE STENT GRAFT BY ROTATING THE HANDLE. CONSEQUENTLY, THE ANEURX CUFF ENDED UP COVERING BOTH RENAL ARTERIES. ATTEMPTS WERE MADE TO PULL THE CUFF DOWNWARD WITH BALLOONS AND WIRES THAT WERE ALREADY IN PLACE. THE CUFF MOVED SLIGHTLY DOWNWARDS ON THE RIGHT SIDE AND TILTED OVER, ON THE LEFT SIDE, THE CUFF WOULD NOT MOVE, BECAUSE IT WAS CATCHING ON THE BIFURCATED STENT GRAFT DISTALLY. THE PHYSICIAN ELECTED TO OPEN THE PT AND EXPLANT THE ANEURX CUFF; A DACRON GRAFT WAS THEN SEWN TO THE AORTA PROXIMALLY AND TO THE REMAINDER OF THE STENT GRAFT DISTALLY. THE ORIGINAL STENT GRAFTS WERE NOT EXPLANTED, AND THE EXPLANTED ANEURX CUFF WAS DISCARDED. 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 V00365182

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention