BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDURANT II ILIAC STENT GRAFT

    MDR report key: 3930265 · Received July 11, 2014

    Report

    Report Number
    2953200-2014-01379
    Event Type
    Malfunction
    Date Received
    July 11, 2014
    Date of Event
    June 16, 2014
    Report Date
    July 22, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCLUSION: ANOTHER MANUFACTURER¿S DEVICE.

    Description of Event or Problem · 1

    THE DEVICE WAS RETURNED FOR EVALUATION AND THE ANALYSIS HAS BEEN COMPLETED. THE COMPLAINT WAS CONFIRMED; THERE WAS AN OBSTRUCTION IN THE TAPERED TIP LUMEN THAT PREVENTED IRRIGATION. THE ROOT CAUSE OF THE EVENT COULD NOT BE CONCLUSIVELY DETERMINED; HOWEVER, WAS MOST LIKELY MANUFACTURING RELATED. THE CAUSE OF THE OCCLUSION WAS DUE TO HYDROPHILIC COATING ENTERING THE TAPERED TIP LUMEN.

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS SELECTED FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. VESSEL MORPHOLOGY WAS NOT A FACTOR. IT WAS REPORTED THAT DURING FLUSHING OF THE DEVICE THE PHYSICIAN NOTICED THAT THE HEP-SALINE SOLUTION WAS EXITING OUT THE SHEATH DOWN THE GRAFT COVER AND NOT EXITING THE NOSE CONE. THE NOSE CONE APPEARED TO BE BLOCKED. ANOTHER MEDTRONIC STENT GRAFT 16X16X82 WAS SELECTED AND FLUSHED PROPERLY AND WAS IMPLANTED WITHOUT ISSUE. NO CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    406495 ENDURANT II ILIAC STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V04189168

    Patients

    Seq Age Sex Outcome Treatment
    1