BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 1171397 · Received September 22, 2008

    Report

    Report Number
    2953200-2008-00845
    Event Type
    Injury
    Date Received
    September 22, 2008
    Date of Event
    August 27, 2008
    Report Date
    August 29, 2008
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL: RESULTS: VERY SHORT AORTIC NECK), (ENDOLEAK). CONCLUSION CODE - VERY SHORT AORTIC NECK. SECONDARY INTERVENTION.

    Description of Event or Problem · 1

    A TALENT STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. THE PT HAS A VERY SHORT AORTIC NECK. IT WAS REPORTED THE FINAL ANGIOGRAM REVEALED A TYPE I ENDOLEAK. THE PHYSICIAN BELIEVES THAT IT MAY BE POSSIBLE THAT THE TYPE I ENDOLEAK WAS CAUSED BY MINIMAL FIXATION OF THE STENT GRAFT TO THE VESSEL WALL, DUE TO THE SHORT AORTIC NECK. THE PHYSICIAN TREATED THE PATIENT WITH ANOTHER MANUFACTURER'S STENT. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PT IS FINE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention