BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLITAIRE FR

    MDR report key: 4233237 · Received November 6, 2014

    Report

    Report Number
    2029214-2014-00632
    Event Type
    Injury
    Date Received
    November 6, 2014
    Date of Event
    October 4, 2014
    Report Date
    October 9, 2014
    Manufacturer
    COVIDIEN
    Product Code
    NRY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE EVENT WILL NOT BE RETURNED AS THE STENT REMAINS IN THE PATIENT AND THE PUSHWIRE WAS DISCARDED.(B)(4).

    Description of Event or Problem · 1

    INFORMATION RECEIVED FROM THE (B)(6) CLINICAL STUDY. TREATMENT OF AN ACUTE STROKE IN THE RIGHT ICA (INTERNAL CAROTID ARTERY). THE PATIENT¿S ANATOMY WAS SEVERE IN TORTUOSITY. ON (B)(6) 2014, THE PATIENT UNDERWENT AN EMERGENCY MECHANICAL THROMBECTOMY. DURING THE PROCEDURE, THE PHYSICIAN USED A SOLITAIRE DEVICE FOR THE M2 AREA OCCLUDED WITH THROMBUS AND REMOVED THE THROMBUS FROM M2. UPON REMOVING THE SOLITAIRE FROM THE PATIENT, IT GOT CAUGHT ON AN INDWELLING STENT THAT HAD BEEN DEPLOYED IN THE CAROTID AND COULD NOT BE EITHER PULLED OR PUSHED. FOR THAT REASON, THE PHYSICIAN REMOVED THE MARKSMAN MICROCATHETER AND TRIED TO CAPTURE THE SOLITAIRE WITH 6FR JB2, BUT WAS NOT ABLE TO REMOVE THE SOLITAIRE SO THE PHYSICIAN INTENTIONALLY BROKE THE SOLITAIRE AT THE PROXIMAL RADIOPAQUE MARKER TO REMOVE THE PUSHWIRE. THE SOLITAIRE REMAINS INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT FURTHER ACTION. THE PHYSICIAN COMMENTED THAT THE GUIDING CATHETER SHOULD HAVE BEEN DELIVERED MORE DISTAL TO THE STENT DEPLOYED IN THE CAROTID, BUT THE GUIDING CATHETER INSERTED WAS TOO SHORT FOR THAT. ON (B)(6) 2014, LEFT HEMIPLEGIA AND UNILATERAL SPATIAL NEGLECT WERE OBSERVED DURING FOLLOW-UP. THESE SYMPTOMS WERE THE SUBSEQUENT COMPLICATION OF THE ACUTE STROKE AND WERE NOT CAUSED BY THE SOLITAIRE DEVICE OR PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714792 SOLITAIRE FR FLOW RESTORATION NRY COVIDIEN SFR-4-20 9855393

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability