BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT

    MDR report key: 3041544 · Received April 8, 2013

    Report

    Report Number
    2953200-2013-00643
    Event Type
    Injury
    Date Received
    April 8, 2013
    Date of Event
    March 14, 2013
    Report Date
    March 14, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION RESULTS: INHERENT RISK OF PROCEDURE (ENDOLEAK, MIGRATION). PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (DISEASE PROGRESSION; ILIAC DILATATION). EVALUATION CONCLUSION: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (DISEASE PROGRESSION; ILIAC DILATATION).

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN UNKNOWN SIZE ABDOMINAL AORTIC ANEURYSM APPROXIMATELY FOURTEEN MONTHS AGO. IT WAS REPORTED THAT THE PATIENT WAS TREATED FOR A TYPE IB ENDOLEAK. THE TYPE IB ENDOLEAK WAS FROM BOTH RIGHT AND LEFT COMMON ILIAC ARTERIES. THERE WAS NO PROXIMAL ENDOLEAK. THE PATIENT'S RIGHT ILIAC HAD DILATED AND THE GRAFT APPEARED TO HAVE PULLED UP INTO A LARGER PART OF THE ILIAC. THE PHYSICIAN EXTENDED WITH A 16X24X156 FROM THE FLOW DIVIDER DOWN TO THE RIGHT HYPOGASTRIC ARTERY TO SEAL JUST OVER 2 CM. THE LEFT COMMON ILIAC HAD DILATED TO OVER 3 CM IN DIAMETER. THE PHYSICIAN PLUGGED THE LEFT HYPOGASTRIC ARTERY AND EXTENDED INTO THE LEFT EXTERNAL WITH A 16X13X199 AND A 13X13X82. THE PATIENT'S ABDOMINAL AORTIC ANEURYSM HAD ENLARGED, BUT WAS ASYMPTOMATIC. THE ENDOLEAKS RESOLVED POST PROCEDURE AND THE PATIENT IS FINE. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143058 ENDURANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V01010349

    Patients

    Seq Age Sex Outcome Treatment
    1 00076 YR Required Intervention