BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT STENT GRAFT SYSTEM WITH XCELERANT - HYDRO

    MDR report key: 1963340 · Received January 14, 2011

    Report

    Report Number
    2953200-2011-00122
    Event Type
    Injury
    Date Received
    January 14, 2011
    Date of Event
    December 17, 2010
    Report Date
    December 17, 2010
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL RESULTS AND CONCLUSION: (OCCLUSION, VESSEL DISSECTION), (TORTUOUS, DISEASED ANATOMY).

    Description of Event or Problem · 1

    A TALENT ABDOMINAL STENT GRAFT SYS WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF A 6.1 CM ABDOMINAL AORTIC ANEURYSM. THE PT HAD CHALLENGING ILIACS AND THEY ALSO COILED THE RIGHT SIDE. THE PT PRESENTED WITH LIMB THROMBOSIS AND A POSSIBLE DISSECTION OF THE RIGHT COMMON FEMORAL ARTERY. THE PT IS ON A THROMBOLYSIS REGIMEN NOW WITH HOPE OF GETTING THAT LIMB REOPENED. THE PHYSICIAN THINKS IT HAS TO DO WITH HIS TORTUOUS, DISEASED ANATOMY AND NOT NECESSARILY THE STENT GRAFT. THE PT HAD TPA AND THE STENT REOPENED. THE PT WENT HOME AND NO LONGER HAS AN OCCLUSION. NO ADDITIONAL 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 V00543060

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention