BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT II ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 2943932 · Received February 5, 2013

    Report

    Report Number
    2953200-2013-00192
    Event Type
    Injury
    Date Received
    February 5, 2013
    Date of Event
    January 9, 2013
    Report Date
    January 10, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION METHOD, RESULTS AND CONCLUSION: (FILM). (ENDOLEAK). (ANGULATED AORTIC NECK). (AORTIC NECK ANGULATION GREATER THAN 60 DEGREES).

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48259 ENDURANT II ABDOMINAL STENT GRAFT SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V01722115

    Patients

    Seq Age Sex Outcome Treatment
    1 00082 YR Required Intervention