BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT

    MDR report key: 3852237 · Received June 5, 2014

    Report

    Report Number
    2953200-2014-01134
    Event Type
    Injury
    Date Received
    June 5, 2014
    Report Date
    May 16, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. THE LEFT ILIAC DIAMETER AT END OF IPSI LIMB IS 23.6MM IN DIAMETER. THE MID-DISTAL LEFT ILIAC MEASURES 17-19MM IN DIAMETER. THE LENGTH FROM THE FLOW DIVINDER TO LEFT HYPO MEASURES 156MM IN LENGTH. IT WAS REPORTED THAT THE PATIENT HAD A FOLLOW UP CT SCAN WHICH OBSERVED A DISTAL TYPE I ENDOLEAK COMING FROM THE IPSILATERAL LIMB. IT APPEARS THAT THE STENT GRAFT WAS PULLED UP ON TO THE ANEURYSM SAC EITHER BY NORMAL ANEURYSMAL REMODELING OR ILIAC DILATATION DUE TO DISEASE PROGRESSION. COMPARATIVE IMAGES WERE NOT AVAILABLE. AN INTERVENTION WAS PERFORMED AND THE PHYSICIAN RELINED THE IPSILATERAL LIMB FROM DISTAL TO THE FLOW DIVIDER TO THE LEFT HYPOGASTRIC ARTERY, RESOLVING THE DISTAL TYPE I ENDOLEAK. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329543 ENDURANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V00901121

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention