BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANEURX STENT GRAFT WITH XCELERANT DELIVERY SYSTEM

    MDR report key: 1841302 · Received September 10, 2010

    Report

    Report Number
    2953200-2010-01729
    Event Type
    Injury
    Date Received
    September 10, 2010
    Date of Event
    August 1, 2010
    Report Date
    August 12, 2010
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4), RESULTS: ENDOLEAK, MIGRATION. AORTIC NECK ANGULATION AND DILATATION, TYPE 2 ENDOLEAK.

    Description of Event or Problem · 1

    AN ANEURX STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM APPROXIMATELY 50 MONTHS AGO. ANEURYSM AND VESSEL MORPHOLOGY FROM THE TIME OF IMPLANT ARE UNK. THIS PT PRESENTED WITH PAIN AND ALSO HAD KIDNEY STONES APPROXIMATELY 1 MONTH AGO. IT WAS REPORTED THAT THERE WAS DISTAL MIGRATION OF APPROXIMATELY 10 MM NOTED WITH A PROXIMAL TYPE 1 ENDOLEAK DUE TO DISEASE PROGRESSION AND NECK ANGULATION. IT IS UNCLEAR WHETHER THE PAIN WAS ASSOCIATED WITH THE KIDNEY STONES OR THE ENDOLEAK. AT THE TIME OF MIGRATION, THE ANEURYSM WAS 5.4 CM IN DIAMETER, WHICH IS 1 CM LARGER THAN A PREVIOUS MEASUREMENT OF 4 CM ON AN UNK DATE. THE NECK IS CURRENTLY 19 MM IN DIAMETER AT 1 CM BELOW THE RENALS AND 23 MM IN DIAMETER AT 1.5 CM BELOW. THE NECK MAY HAVE DILATED AND IT HAD SOME ANGULATION. THE PT WAS FOUND TO ALSO HAVE A TYPE 2 ENDOLEAK FROM PATENT LUMBARS. AN INTERVENTION, WITH AN AORTIC CUFF WAS PERFORMED APPROXIMATELY 4 WEEKS AGO. ACCESS WAS TRIED ON THE LEFT SIDE, AS THE RIGHT SIDE HAD AN ILIAC STENT IN PLACE. THE DEVICE WAS TRIED ONE TIME, BUT WAS GETTING HUNG UP PAST THE ANEURX BIFURCATION. THE ANEURX BIFURCATED STENT GRAFT WAS BALLOONED, AND THE DEVICE RE-INSERTED. THE DEVICE AGAIN GOT STUCK, IT WAS REMOVED, AND A KINK WAS NOTED. HOWEVER, THE DEVICE WAS RE-INSERTED FOR A THIRD TIME. ON THE 3RD ATTEMPT, THE DEVICE RUPTURED THE ILIAC ARTERY (SEE MFR# 2953200-2010-01730). AT THIS POINT, THE DECISION WAS MADE TO SURGICALLY CONVERT TO AN OPEN REPAIR, AND THE GRAFTS WERE EXPLANTED. THE DEVICES WERE 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 STENT GRAFT WITH XCELERANT DELIVERY SYSTEM MIH MEDTRONIC CARDIOVASCULAR NA 791836

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention