BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPLETE SE ILIAC

    MDR report key: 3052202 · Received April 11, 2013

    Report

    Report Number
    9612164-2013-00409
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    February 18, 2013
    Report Date
    March 12, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIO
    PMA / PMN Number
    P090006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: NO RESULTS AVAILABLE SINCE NO EVALUATION PERFORMED. INHERENT RISK OF PROCEDURE. UNABLE TO CONFIRM COMPLAINT. KNOWN INHERENT RISK OF PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN DEPLOYED A COMPLETE SE PERIPHERAL STENT IN A LESION LOCATED IN THE POPLITEAL WHICH EXHIBITED 70% STENOSIS, MODERATE CALCIFICATION AND MILD TORTUOSITY. THE LESION HAD BEEN PRE-DILATED PRIOR TO STENT PLACEMENT. IT WAS REPORTED THAT WHEN THE SURGEON TRIED TO REMOVE THE DELIVERY SYSTEM, THE TIP OF THE STENT SHEATH GOT STUCK INTO THE STENT. AS A RESULT, THE STENT MOVED HOWEVER NO PATIENT INJURY WAS REPORTED AND NO OTHER CLINICAL SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155634 COMPLETE SE ILIAC STENT, ILIAC NIO MEDTRONIC IRELAND 0006545045

    Patients

    Seq Age Sex Outcome Treatment
    1 00073 YR