BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPLETE SE ILIAC

    MDR report key: 3053422 · Received April 11, 2013

    Report

    Report Number
    9612164-2013-00410
    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 (DEVICE NOT RETURNED FOR EVALUATION). CONCLUSION; DEVICE OR PROCEDURAL IMAGES NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN DEPLOYED A COMPLETE SE PERIPHERAL STENT THE A POPLITEAL LESION WHICH EXHIBITED MODERATE CALCIFICATION AND TORTUOSITY. THE LESION HAD BEEN PRE-DILATED PRIOR TO STENT DEPLOYMENT. IT WAS REPORTED THAT WHEN THE SURGEON TRIED TO REMOVE THE DELIVERY SYSTEM, THE TIP OF THE STENT SHEATH GOT STUCK INTO THE STENT. NO PATIENT INJURY WAS REPORTED AND NO CLINICAL SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154453 COMPLETE SE ILIAC STENT, ILIAC NIO MEDTRONIC IRELAND 0005922354

    Patients

    Seq Age Sex Outcome Treatment
    1