BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPIDERFX EMBOLIC PROTECTION DEVICE

    MDR report key: 1190293 · Received October 6, 2008

    Report

    Report Number
    2183870-2008-00132
    Event Type
    Injury
    Date Received
    October 6, 2008
    Date of Event
    September 22, 2008
    Report Date
    September 23, 2008
    Manufacturer
    EV3 INC.
    Product Code
    NTE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REFERENCE MDR 2183870-2008-00133 FOR OTHER DEVICE USED IN THIS PROCEDURE. DEVICE NOT RETURNED TO MFR.

    Description of Event or Problem · 1

    PT ENROLLED INTO THE CREATE PAS TRIAL. PT RECEIVED A LEFT CAROTID STENT IN 2008. SHE BECAME HYPOTENSIVE AFTER POST BALLOON DILATION, AND WAS STARTED ON NEO-SYNEPHRINE DRIP AFTER RECEIVING 2 BOLUSES. SHE HAD TRANSIENT DEFICIT WITH MILD CONFUSION AND MILD WEAKNESS OF THE RIGHT SIDE. THE FILTER WAS RETRIEVED AND SHOWED SIGNIFICANT DEBRIS. THE PT'S SYMPTOMS RECOVERED AFTER A FEW MINS. SHE RETURNED TO BASELINE. SHE WAS TRANSFERRED TO ICU, WHERE SHE HAD RECURRENCE OF HER SYMPTOMS OF RIGHT ARM WEAKNESS AND SPEECH DIFFICULTIES. SHE HAD A STAT PLAIN CT SCAN THAT DID NOT SHOW ANY ACUTE CHANGES. SHE REMAINED ON THE NEO DRIP WITH SYSTOLIC BLOOD PRESSURE RANGE 90-110 MMHG. NEUROLOGY SAW THE PT AROUND ON THE NEXT DAY. REPEAT CT SCAN WAS DONE, NO ACUTE CHANGES, CAROTID ULTRASOUND SHOWED NORMAL APPEARANCE OF THE LEFT CAROTID STENT. SPEECH THERAPY, OT, AND PT WERE ORDERED. THE DIAGNOSES WAS CRESCENDO TIA VERSUS STOKE. BY AFTERNOON THE PT HAD IMPROVED, MOVING RIGHT ARM AND SPEAKING MORE CLEARLY. ON THE FOLLOWING DAY, THE PT WAS IMPROVED WITH SOME SLIGHT DEFICIT IN RIGHT ARM AND SPEECH. SHE WAS DISCHARGED FROM THE HOSPITAL TO HOME ON THE NEXT DAY. IT WAS DOCUMENTED THAT THE PT STILL HAS SLIGHT RIGHT UPPER EXTREMITY DEFICIT. THE PT C/O DIFFICULTY WRITING. HER NIHHS WAS 5 IN THE MORNING AFTER THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPIDERFX EMBOLIC PROTECTION DEVICE NTE EV3 INC. SPD2-US-050-320 4781022

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Other 5X30MM| ANGIOSEAL RT. GROIN| BOSTON SCIENTIFIC STERLING BALLOONS 4X40MM| CORDIS CBL GUIDE 8FR