BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT

    MDR report key: 4221678 · Received November 3, 2014

    Report

    Report Number
    2953200-2014-02286
    Event Type
    Injury
    Date Received
    November 3, 2014
    Date of Event
    October 6, 2014
    Report Date
    October 7, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. ANEURYSM AND VESSEL MORPHOLOGY WAS NOT REPORTED. IT WAS REPORTED THAT A CT REVEALED THAT THE PATIENT¿S ANEURYSM WAS ENLARGED DUE TO A TYPE IA AND A TYPE IB ENDOLEAK. THE PHYSICIAN PERFORMED AN INTERVENTION WHERE EMBOLIZATION WAS INTENTIONALLY CARRIED OUT PUTTING MICRO COIL AND N-BUTYL CYANOACRYLATE (NBCA) IN THE ANEURYSM TO RESOLVE THE TYPE IA ENDOLEAK. AS FOR TYPE IB ENDOLEAK, AN ADDITIONAL LIMB 16X13X93 WAS ADDED IN THE EXTERNAL ILIAC ARTERY (EIA) LANDING AFTER EMBOLIZATION OF LEFT INTERNAL ILIAC ARTERY (IIA). NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702385 ENDURANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V01125021

    Patients

    Seq Age Sex Outcome Treatment
    1 00085 YR Required Intervention