BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TALENT STENT GRAFT SYSTEM WITH XCELERANT - HYDRO

    MDR report key: 1992868 · Received February 4, 2011

    Report

    Report Number
    2953200-2011-00272
    Event Type
    Malfunction
    Date Received
    February 4, 2011
    Date of Event
    January 6, 2011
    Report Date
    January 6, 2011
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: (VESSEL MORPHOLOGY); (KINK); (REINSERTION OF KINKED DEVICE). CONCLUSION: (VESSEL MORPHOLOGY); (REINSERTION OF KINKED DEVICE).

    Description of Event or Problem · 1

    A TALENT STENT GRAFT SYSTEM WAS IMPLANTED INTO A PT FOR THE ENDOVASCULAR TREATMENT OF A 5.2 CM ABDOMINAL AORTIC ANEURYSM. AORTIC NECK WAS 18 MM LONG, REVERSE FUNNEL SHAPED WITH A 26 MM DIAMETER AT THE RENALS AND 21 MM IN DIAMETER ABOVE THE AAA, HAD 45 DEGREE ANGULATION, AND MILD CALCIFICATION WITHOUT THROMBUS. VESSELS WERE MODERATELY TO SEVERELY CALCIFIED AND ABOUT 11 MM IN DIAMETER. THE TALENT BIFUR DEVICE WAS FIRST TRIED ON THE RIGHT SIDE, BUT COULD NOT BE ADVANCED TO THE ANEURYSM DUE TO THE VESSEL MORPHOLOGY. THE RIGHT COMMON ILIAC WAS BALLOONED, AND ADVANCEMENT WAS TRIED AGAIN WITHOUT SUCCESS. THERE WAS EXCESSIVE FORCE APPLIED TO ADVANCE THE DEVICE, WHICH CAUSED A SMALL BEND IN THE GRAFT COVER. ADVANCEMENT WAS THEN TRIED ON THE LEFT SIDE WITHOUT SUCCESS; THE LEFT SIDE WAS BALLOONED, BUT ADVANCEMENT WAS STILL UNSUCCESSFUL. THE FIRST DEVICE WAS REMOVED AND DISCARDED. A SECOND TALENT DEVICE WAS THEN ABLE TO BE ADVANCED WITHOUT ISSUES TO COMPLETE THE CASE. NO CLINICAL SEQUELAE WERE REPORTED, AND THE PT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT STENT GRAFT SYSTEM WITH XCELERANT - HYDRO MIH MEDTRONIC CARDIOVASCULAR GALWAY NA V00487622

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR