BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANEURX STENT GRAFT (HDM FLEXIBLE) ITH XPEDIENT

    MDR report key: 569555 · Received February 1, 2005

    Report

    Report Number
    2953200-2005-01023
    Event Type
    Injury
    Date Received
    February 1, 2005
    Date of Event
    January 3, 2005
    Report Date
    January 3, 2005
    Manufacturer
    MEDTRONIC VASCULAR
    Product Code
    MIH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A 28 MM DIAMETER X 16 MM DIAMETER X 13.5 CM LENGTH ANEURX BIFURCATED STENT GRAFT WAS IMPLANTED INTO A PT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AROTIC ANEURYSM. THE ANEURYSM WAS GREATER THAN 5 CM IN DIAMETER AND ENDED APPROXIMATELY 2 CM ABOVE THE BIFURCATION. THE AORTA WAS VERY TIGHT DISTALLY. THE PHYSICIAN REPORTED THAT IT WAS NOT POSSIBLE TO CANNULATE THE RIGHT LIMB OF THE AORTA DUE TO THE DISTAL AORTIC NECK. WITH PERSISTENCE, EVENTUALLY THERE WAS AN INJURY OF THE DISTAL AORTA AND EXTRAVASION OF CONTRAST. THE PT'S BLOOD PRESSURE DROPPED INTO THE 70'S MOMENTARILY; THEREFORE, SURGICAL CONVERSION WAS QUICKLY PERFORMED AND A HOLE WAS PRESENT IN THE DISTAL AORTA. WHEN THE ANEURYSM SAC WAS OPENED THE LIMB WAS NOTED TO BE FLUSH WITH THE BOTTOM OF THE AORTIC SAC, CONFIRMING THE INABILITY TO CANNULATE THE GATE. THE STENT GRAFT WAS COMPLETELY REMOVED AND CONVENTIONAL GRAFT WAS SEWN IN. AT THE END OF THE PROCEDURE THERE WAS SOME LEAKING PRESENT BEHIND THE GRAFT WITH THE DISTAL ANASTOMOSIS AND REPAIR SUTURES WERE USED TO RESOLVE THAT. THE PT HAD SOME HYPOTENSION BUT WAS RESOLVED WITH TIME AND VOLUME RECESSITATION. NO ADD'L SEQUELAE WERE REPORTED AND THE PT IS FINE. THE DEVICE WAS DISCARDED AFTER THE PROCEDURE AND WILL NOT BE RETURNED TO MEDTRONIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANEURX STENT GRAFT (HDM FLEXIBLE) ITH XPEDIENT AAA STENT GRAFT MIH MEDTRONIC VASCULAR NA 151126

    Patients

    Seq Age Sex Outcome Treatment
    1 93 YR Required Intervention