BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT II

    MDR report key: 4122468 · Received September 26, 2014

    Report

    Report Number
    2953200-2014-01946
    Event Type
    Injury
    Date Received
    September 26, 2014
    Date of Event
    September 18, 2014
    Report Date
    September 30, 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 II STENT GRAFT SYSTEM WAS IMPLANTED FOR THE EMERGENT ENDOVASCULAR TREATMENT OF AN UNKNOWN SIZE AND 110 MM IN LENGTH ABDOMINAL AORTIC ANEURYSM. THE PROXIMAL NECK WAS 17 MM IN DIAMETER AND 10 MM IN LENGTH, 30 DEGREES OF ANGULATION. THE LEFT COMMON ILIAC ARTERY WAS 12 MM IN DIAMETER. IT WAS REPORTED THAT BECAUSE THE GUIDEWIRE TOOK THE SHORTEST PATH IN THE BLOOD VESSEL RATHER THAN RUNNING ALONG THE VESSEL SHAPE, THE DEVICE WAS DEPLOYED RATHER OBLIQUELY TO THE VESSEL, THUS CAUSING THE DEVICE TO BE RATHER UNDERSIZED. THE OPERATION WAS COMPLETED AFTER THE MAIN BODY AND LIMB WERE DEPLOYED, HOWEVER, THE POST-OPERATIVE ANGIOGRAPHY SHOWED A TYPE 1A ENDOLEAK. AN AORTIC CUFF WAS PLACED TO CORRECT THE SITUATION; THE LEAK WAS REDUCED MODERATELY BUT NOT COMPLETELY. ANOTHER MANUFACTURER¿S EXCLUDER WAS DEPLOYED AS AN ADDITIONAL MEASURE, AND THIS TIME, THE LEAK HAS CONSIDERABLY REDUCED, PROBABLY BECAUSE THE DEVICE WAS SUCCESSFULLY ATTACHED TO THE NATIVE VESSEL WHEN THE BLOOD VESSEL WAS STRAIGHTENED. THE PHYSICIAN IS MONITORING THE PATIENT. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE. THE PHYSICIAN COMMENTED THAT IT WAS DIFFICULT DUE TO AN EMERGENCY CASE. NOTE: BECAUSE THIS WAS AN EMERGENCY CASE, THE PHYSICIAN USED THE ORDERED DEVICE WITHOUT BEING ABLE TO MEASURE THE SIZE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN EXCLUDER CUFF WAS IMPLANTED RESOLVING THE ENDOLEAK. THE PHYSICIAN IS MONITORING THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600914 ENDURANT II SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V04165701

    Patients

    Seq Age Sex Outcome Treatment
    1 00083 YR Required Intervention