BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT II

    MDR report key: 3802724 · Received May 9, 2014

    Report

    Report Number
    2953200-2014-00958
    Event Type
    Injury
    Date Received
    May 9, 2014
    Date of Event
    April 15, 2014
    Report Date
    April 15, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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 A GREATER THAN 5.0 CM ABDOMINAL AORTIC ANEURYSM. VESSEL MORPHOLOGY WAS NOT REPORTED. DURING THE INDEX PROCEDURE IT WAS NOTED THAT TOUCH UP BY KISSING BALLOONS WAS PERFORMED DUE TO THE FLOW DIVIDER BEING COMPRESSED. THE PHYSICIAN USED TWO 16X4 PTA BALLOONS AND THE STENT GRAFT OPENED UP. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. IT WAS REPORTED THAT THE PATIENT SUFFERED A STROKE THE FOLLOWING DAY AND MEDICAL CARE HAS BEEN GIVEN TO THE PATIENT. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL CONTINUE TO BE MONITORED BY THE PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280369 ENDURANT II SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V04201972

    Patients

    Seq Age Sex Outcome Treatment
    1 00073 YR