BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 2964092 · Received February 15, 2013

    Report

    Report Number
    2953200-2013-00274
    Event Type
    Injury
    Date Received
    February 15, 2013
    Date of Event
    February 27, 2013
    Report Date
    February 27, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: ENDOLEAK. DISEASE PROGRESSION, ILIAC LIMB DILATATION. CONCLUSION: DISEASE PROGRESSION, ILIAC LIMB DILATATION.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED AS FOLLOWS: THE PATIENT WAS TREATED WITH AN ENDURANT ILIAC EXTENSION LIMB.

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM APPROXIMATELY FOUR MONTHS AGO. THE RIGHT ILIAC ARTERY WAS SEVERELY TORTUOUS AND ANEURYSMAL. THE STENT GRAFTS WERE IMPLANTED WITHOUT COMPLICATION. IT WAS REPORTED THAT DURING A ROUTINE FOLLOW-UP VISIT APPROXIMATELY ONE MONTH AGO, AN ULTRASOUND REVEALED A DISTAL TYPE I ENDOLEAK. A CT SCAN DEMONSTRATED THAT THE DISTAL TYPE I ENDOLEAK WAS IN THE RIGHT ILIAC LIMB AS A RESULT OF DISEASE PROGRESSION WITH ILIAC LIMB DILATATION. AT THE TIME OF IMPLANT THERE WAS MARGINAL AORTIC NECK SEAL. THE ILIAC LIMB WAS 17 MM IN DIAMETER AND CURRENTLY THE ILIAC LIMB IS 26 MM IN DIAMETER. NO INTERVENTION HAS BEEN PERFORMED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68550 ENDURANT ABDOMINAL STENT GRAFT SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V00898822

    Patients

    Seq Age Sex Outcome Treatment
    1 00085 YR Required Intervention