BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT

    MDR report key: 4233380 · Received November 6, 2014

    Report

    Report Number
    2953200-2014-02344
    Event Type
    Injury
    Date Received
    November 6, 2014
    Date of Event
    October 13, 2014
    Report Date
    October 13, 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 IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 6 CM IN DIAMETER ABDOMINAL AORTIC ANEURYSM. VESSEL MORPHOLOGY AT THE TIME OF IMPLANT WAS NOT REPORTED. CURRENTLY, THERE IS DISEASE PROGRESSION WITH ILIAC LIMB DILATATION. A RECENT ROUTINE FOLLOW UP CT REVEALED THAT THERE IS A DISTAL TYPE I ENDOLEAK. THE RIGHT COMMON ILIAC DILATED MODERATELY AND THE SEAL WITH THE ILIAC LIMB WAS LOST, THE LIMB SUBSEQUENTLY MIGRATED PROXIMAL INTO THE DISTAL AORTA. THE PHYSICIAN ELECTED TO IMPLANT AN ENDURANT ILIAC LIMB EXTENSION 16X24X93 AND THE ENDOLEAK WAS RESOLVED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    713396 ENDURANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V00554434

    Patients

    Seq Age Sex Outcome Treatment
    1 00070 YR Required Intervention