BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT II

    MDR report key: 3944131 · Received July 18, 2014

    Report

    Report Number
    2953200-2014-01402
    Event Type
    Injury
    Date Received
    July 18, 2014
    Date of Event
    June 24, 2014
    Report Date
    June 24, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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 FINAL ANGIOGRAPHY AT THE END OF THE INDEX PROCEDURE IDENTIFIED A POSSIBLE TYPE III (FABRIC) IN THE MIDDLE OF THE STENT GRAFT. THE PHYSICIAN ADDED ANOTHER ENDURANT LIMB INSIDE THE FIRST ONE AND THE ENDOLEAK WAS RESOLVED. THE CAUSE PER THE PHYSICIAN STATEMENT IS UNKNOWN. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS DOING FINE. THE REVIEW OF SEVERAL RETURNED ANGIO IMAGES FROM A VIDEO, REVEALED THAT THE IPSILATERAL LIMB AND EXTENSION WERE POSITIONED WITHIN THE RIGHT ILIAC, AND THE CONTRA LIMB AND EXTENSION WITHIN THE LEFT ILIAC. THE LEFT COMMON ILIAC APPEARS TO BE ANEURYSMAL, AND THE DISTAL END OF THE LEFT LIMB LANDED NEAR THE LEFT COMMON/EXTERNAL ILIAC BIFURCATION. THERE IS CONTRAST (BLUSH) SEEN WITHIN THE LEFT COMMON ILIAC ARTERY, FROM A LIKELY ENDOLEAK NEAR THE DISTAL END OF THE LEFT LIMB. THE ENDOLEAK MAY BE A TYPE III FABRIC, BUT CANNOT RULE OUT A TYPE IV ENDOLEAK. ANOTHER ILIAC LIMB IS THEN SEEN PLACED TO THE DISTAL LEVEL OF THE PREVIOUSLY PLACED ILIAC LIMB, OVERLAPPING THE AREA OF THE ENDOLEAK, AND FINAL ANGIO IMAGE SHOWED THAT THE ENDOLEAK APPEARED TO HAVE RESOLVED. THE CAUSE OF THE ENDOLEAK COULD NOT BE DETERMINED FROM THESE IMAGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422290 ENDURANT II SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V04656436

    Patients

    Seq Age Sex Outcome Treatment
    1 00080 YR Required Intervention