BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPLETE SE ILIAC

    MDR report key: 2933101 · Received January 29, 2013

    Report

    Report Number
    9612164-2013-00108
    Event Type
    Injury
    Date Received
    January 29, 2013
    Date of Event
    December 28, 2012
    Report Date
    December 31, 2012
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIO
    PMA / PMN Number
    P090006
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: (ROOT CAUSE OF THIS EVENT COULD NOT BE DETERMINED, HOWEVER, IT MAY BE PROCEDURAL RELATED). DEFORMATION PROBLEM. CONCLUSION: OPERATIONAL CONTEXT CAUSED OR CONTRIBUTED TO THE EVENT - (ROOT CAUSE OF THIS EVENT COULD NOT BE DETERMINED, HOWEVER, IT MAY BE PROCEDURAL RELATED). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN WAS ATTEMPTING TO DEPLOY A 7MM DIAMETER X 100MM LENGTH COMPLETE SE PERIPHERAL STENT TO TREAT A LESION IN A PATIENT LOCATED IN THE SFA THAT WAS PRE-DILATED. IT WAS REPORTED THAT THE STENT COULD NOT BE DEPLOYED FULLY AND THE END OF THE STENT COULD NOT BE RELEASED FROM THE SHEATH AND WAS STUCK IN THE SHEATH. THE PHYSICIAN HAD TO USE ANOTHER DEVICE TO PUSH THE STENT OUT AND THE PHYSICIAN PULLED THE STENT BACK INTO THE SHEATH AND WAS ABLE TO PULL THE STENT FROM THE PATIENT. A SMALL CUT DOWN WAS PERFORMED TO REMOVE THE DEVICE FROM THE PATIENT AS APPROXIMATELY 1CM OF THE STENT WAS UNABLE TO BE PULLED INTO THE SHEATH. THE PATIENT WAS REPORTED TO BE WELL AFTER THE PROCEDURE. NO OTHER CLINICAL SEQUELAE WERE REPORTED. DEVICE EVALUATION; THE STENT WAS RETURNED OFF THE DELIVERY SYSTEM. THERE WAS SLIGHT DEFORMATION AND BENDING EVIDENT ON THE STENT. THE PROXIMAL END OF THE DISTAL TIP WAS FLARED AND RAISED, INDICATING THAT IT MAY HAVE SNAGGED ON SOMETHING DURING THE PROCEDURE. THE HANDLE WAS ADVANCED AND RETRACTED WITHOUT ISSUE. THERE WAS NO OTHER DAMAGE EVIDENT ON THE DELIVERY SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39232 COMPLETE SE ILIAC STENT, ILIAC NIO MEDTRONIC IRELAND 0005789311

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention