BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT II

    MDR report key: 3830255 · Received May 23, 2014

    Report

    Report Number
    2953200-2014-01056
    Event Type
    Injury
    Date Received
    May 23, 2014
    Date of Event
    April 30, 2014
    Report Date
    May 1, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. VESSEL MORPHOLOGY WAS NOT REPORTED. IT WAS REPORTED THAT FOUR DAYS POST INDEX REPAIR, THE PATIENT PRESENTED WITH A RUPTURE DUE TO A TYPE IA ENDOLEAK. PER THE PHYSICIAN'S STATEMENT WHAT CONTRIBUTED TO THE TYPE IA ENDOLEAK WAS EXCESSIVE CALCIFICATION IN THE AORTIC NECK. THE PHYSICIAN CONVERTED THE PATIENT TO OPEN REPAIR AND EXPLANTED ALL THE STENT GRAFTS DUE TO THE RUPTURE. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307904 ENDURANT II SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V04044098

    Patients

    Seq Age Sex Outcome Treatment
    1 00064 YR Required Intervention