BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT ABDOMINAL BIFURCATED STENT GRAFT SYSTEM

    MDR report key: 1111730 · Received August 14, 2008

    Report

    Report Number
    2953200-2008-00675
    Event Type
    Injury
    Date Received
    August 14, 2008
    Date of Event
    July 15, 2008
    Report Date
    July 15, 2008
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL RESULTS, CONCLUSION: (GRAFT WAS INACCURATELY DELIVERED BY THE USER). SECONDARY INTERVENTION.

    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. ANEURYSM AND VESSEL MORPHOLOGY WERE NOT REPORTED. IT WAS REPORTED THAT THE PHYSICIANS DEPLOYED THE STENT GRAFT RESULTING IN INACCURATE PLACEMENT AND A TYPE I ENDOLEAK. THE STENT GRAFT WAS PLACED LOWER THEN INTENDED. THE PHYSICIAN ELECTED TO IMPLANT AN AORTIC CUFF. NO ADD'L CLINICAL SEQUELAE WERE REPORTED AND THE PT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT ABDOMINAL BIFURCATED STENT GRAFT SYSTEM MIH MEDTRONIC CARDIOVASCULAR NA V00102805

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention