BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT

    MDR report key: 4240913 · Received November 10, 2014

    Report

    Report Number
    2953200-2014-02369
    Event Type
    Injury
    Date Received
    November 10, 2014
    Date of Event
    October 16, 2014
    Report Date
    October 16, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. VESSEL MORPHOLOGY WAS REPORTED AS THE AORTIC NECK IS ANGULATED AND HAS CALCIFICATION. IT WAS REPORTED THAT THE ANGIOGRAM REVEALED THAT THERE WAS A PROXIMAL TYPE I ENDOLEAK. THERE IS ALSO A TYPE II ENDOLEAK PRESENT. THE PHYSICIAN STATED THAT THE PROXIMAL TYPE I ENDOLEAK WAS DUE TO THE ANGULATION AND CALCIFICATION IN THE AORTIC NECK. THE PHYSICIAN IMPLANTED AN ENDURANT 32X32X49. THE PROXIMAL TYPE I ENDOLEAK WAS RESOLVED. NO CLINICAL SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    721910 ENDURANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V04658424

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR Required Intervention