BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT STENT GRAFT SYSTEM

    MDR report key: 2153203 · Received June 23, 2011

    Report

    Report Number
    2953200-2011-01200
    Event Type
    Injury
    Date Received
    June 23, 2011
    Date of Event
    May 26, 2011
    Report Date
    May 26, 2011
    Manufacturer
    MEDTRONIC CARDIOVASCULAR IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION, RESULTS: (ENDOLEAK), (CALCIFIED AND MODERATELY ANGULATED AORTIC NECK WITH THROMBUS SHELF). CONCLUSIONS: (CALCIFIED AND MODERATELY ANGULATED AORTIC NECK WITH THROMBUS SHELF).

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDURANT STENT GRAFT SYSTEM MIH MEDTRONIC CARDIOVASCULAR IRELAND NA V00868336

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention