BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPLETE SE SFA

    MDR report key: 4318517 · Received December 10, 2014

    Report

    Report Number
    9612164-2014-01643
    Event Type
    Malfunction
    Date Received
    December 10, 2014
    Date of Event
    November 13, 2014
    Report Date
    November 13, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIP
    PMA / PMN Number
    P110040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION, RESULTS: PATIENTS CONDITION AFFECTED EFFECTIVENESS OF DEVICE (SEVERELY CALCIFIED LESION); NO RESULTS AVAILABLE SINCE NO EVALUATION PERFORMED; NONE (DEVICE/CINES NOT RETURNED FOR EVALUATION). CONCLUSION, RESULTS: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (SEVERELY CALCIFIED LESION); UNABLE TO CONFIRM COMPLAINT (DEVICE/CINE NOT RETURNED).

    Description of Event or Problem · 1

    A COMPLETE SE PERIPHERAL STENT WAS BEING USED TO TREAT A SEVERELY CALCIFIED POPITEAL AND SFA LESION. THE STENT WAS SUCCESSFULLY DEPLOYED. DURING REMOVAL OF THE DELIVERY SYSTEM, THE TIP GOT CAUGHT ON THE RADIOPAQUE MARKER AND/OR STENT STRUT CAUSING THE STENT TO BECOME DEFORMED. ADDITIONAL BALLOONING WAS REQUIRED. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE BUT EXCESSIVE FORCE WAS NOT USED. DEVICE WAS REMOVED FROM PACKAGING PER IFU. DEVICE WAS INSPECTED PRIOR TO USE WITH NO ISSUES NOTED. DEVICE WAS PREPPED PER IFU. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    802781 COMPLETE SE SFA STENT, SUPERFICIAL FEMORAL ARTERY NIP MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1