BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT ABDOMINAL STENT GRAFT SYSTEM - HYDRO

    MDR report key: 2091670 · Received April 29, 2011

    Report

    Report Number
    2953200-2011-00917
    Event Type
    Injury
    Date Received
    April 29, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 1, 2011
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL, RESULTS: (ARTERIAL TRAUMA/DISSECTION/PERFORATION), (CALCIFIED ILIAC ARTERIES). CONCLUSIONS: (CALCIFIED ILIAC ARTERIES).

    Description of Event or Problem · 1

    A TALENT ABDOMINAL STENT GRAFT SYSTEM WAS ATTEMPTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF A 5.4 CM ABDOMINAL AORTIC ANEURYSM APPROX ONE MONTH AGO. THE AORTIC NECK WAS 31 MM IN DIAMETER AT THE LEVEL OF THE RENAL ARTERIES AND IT WAS 27-28 MM IN DIAMETER 4 CM BELOW THAT. THE EXTERNAL ILIAC ARTERIES WERE 8 MM IN DIAMETER AND HAD SOME CALCIFICATION; THE COMMON ILIAC ARTERIES WERE 11 MM IN DIAMETER AND HAD MODERATE CALCIFICATION, WHICH WAS MORE THAN IN THE EXTERNAL ILIAC ARTERIES. IT WAS REPORTED THAT THE TALENT BIFURCATED STENT GRAFT DELIVERY SYSTEM WAS ATTEMPTED TO BE ADVANCED UP THE LEFT SIDE BUT IT WOULD NOT ADVANCE DUE TO THE VESSEL CALCIFICATION. THE VESSEL WAS DILATED WITH AN 8 MM BALLOON BUT ADVANCEMENT WAS STILL DIFFICULT. A 16 FR SHEATH WAS ATTEMPTED, BUT THE DEVICE STILL COULD NOT ADVANCE. THE DEVICE WAS REMOVED WITH NO KINKS EVIDENT. AN IMAGE WAS TAKEN AND A DISSECTION OF THE LEFT ILIAC ARTERY AT THE LOCATION OF THE LEFT HYPOGASTRIC ARTERY WAS NOTED. THE DECISION WAS MADE TO ABORT THE ENDOVASCULAR PROCEDURE AT THIS POINT, AND THEN IT WAS ALSO NOTED THAT THE ILIAC ARTERY HAD TORN. THE PT WAS STABLE AND WAS TAKEN TO THE OPERATING ROOM FOR AN OPEN CONVERSION AND REPAIR OF THE ILIAC ARTERY. NO ADD'L CLINICAL SEQUELAE WERE REPORTED, AND THE PT IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT ABDOMINAL STENT GRAFT SYSTEM - HYDRO MIH MEDTRONIC IRELAND NA V00391405

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention