BEUDAMED
    FDA Adverse Event Other Summary report: N

    ANEURX STENT GRAFT (FLEXIBLE) WITH XPEDIENT

    MDR report key: 574847 · Received February 18, 2005

    Report

    Report Number
    2953200-2005-01035
    Event Type
    Other
    Date Received
    February 18, 2005
    Date of Event
    December 11, 2004
    Report Date
    December 11, 2004
    Manufacturer
    MEDTRONIC VASCULAR
    Product Code
    MIH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A 28 MM DIAMETER X 16 MM DIAMETER X 16.5 CM ANEURX BIFURCATED STENT GRAFT AND ITS COMPONENTS WERE IMPLANTED IN A PT FOR ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. ANEURYSM MORPHOLOGY AT THE TIME OF IMPLANT IS UNK. VESSEL TORTUOSITY WAS MODERATE WITH SLIGHT CALCIFICATION. IT WAS REPORTED THAT THE PT WAS LOST TO FOLLOW-UP. 42 MONTHS POST IMPLANT, THE PT WAS UNDERGOING A CARDIAC CATHETERIZATION AND THE PHYSICIAN NOTICED THAT THE ABDOMINAL AORTIC STENT GRAFT HAD MIGRATED (MFR.# 2953200-2005-01036). THE AORTIC NECK DILATED WITH 55 DEGREE ANGULATION, DUE TO DISEASE PROGRESSION THE STENT GRAFT HAD MIGRATED 35-40 MM. CT DEMONSTRATED THAT THERE WAS A SEPARATION OF THE BIFURCATED STENT GRAFT AND AORTIC CUFF. THE PHYSICIAN IMPLANTED A TALENT STENT GRAFT HOWEVER; THE STENT GRAFT WAS NOT LONG ENOUGH TO COVER THE SEPARATION OF THE BIFURCATED STENT GRAFT AND THE AORTIC CUFF. THE PHYSICIAN THEN IMPLANTED AN ANEURX AORTIC CUFF TO COVER THE SEPARATION. UPON REMOVAL OF THE ANEURX AORTIC CUFF DELIVERY SYSTEM FROM THE PT THE RUNNER WAS STICKING OUT OF THE GRAFT COVER. IT WAS REPORTED THAT THIS WAS CAUSED DURING RETRACTION OF THE GRAFT COVER ON A SEVERELY ANGLED BEND IN THE ARTERY. THERE WAS NO INJURY TO THE PT. NO ADD'L CLINICAL SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANEURX STENT GRAFT (FLEXIBLE) WITH XPEDIENT AAA STENT GRAFT MIH MEDTRONIC VASCULAR NA 209344

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Other