BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RX ACCUNET EMBOLIC PROTECTION SYSTEM

    MDR report key: 798926 · Received December 20, 2006

    Report

    Report Number
    3004742046-2006-00539
    Event Type
    Injury
    Date Received
    December 20, 2006
    Date of Event
    October 4, 2006
    Report Date
    November 22, 2006
    Manufacturer
    GUIDANT ENDOVASCULAR SOLUTIONS
    Product Code
    NFA
    PMA / PMN Number
    k052166
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RX ACCULINK PART #1011343-30, LOT #6091851 REFERENCED IS BEING FILED UNDER MFR #3004742046-2006-00538.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: FAILURE TO DEPLOY. SYMPTOMS/AE: HYPOPERFUSION, LEFT ARM AND LEFT LEG WEAKNESS, RIGHT GAZE DEVIATION AND LEFT FIELD CUT. TIME OF SYMPTOMS/AE: DURING THE PROCEDURE. IT WAS REPORTED THAT, DURING A RIGHT CAROTID ARTERY STENTING PROCEDURE, DURING ATTEMPTED ACCUNET FILTER PLACEMENT, THE PATIENT DEVELOPED LEFT ARM AND LEG WEAKNESS, RIGHT GAZE DEVIATION, AND LEFT FIELD CUT WHICH WERE ATTRIBUTED TO CEREBRAL HYPOPERFUSION. ACCUNET PLACEMENT WAS UNSUCCESSFUL, DUE TO VESSEL TORTUOSITY, AND THE STENTING PROCEDURE WAS COMPLETED WITHOUT THE USE OF AN EMBOLIC PROTECTION DEVICE. THE SYMPTOMS INITIALLY RESOLVED QUICKLY WITH SOME RESIDUAL LEFT ARM AND LEG WEAKNESS; HOWEVER, TWO DAYS FOLLOWING THE PROCEDURE, THE PATIENT DEVELOPED LEFT ARM AND LEG FLACCIDITY. THE PATIENT WAS DISCHARGED TO A REHABILITATION FACILITY 6 DAYS LATER. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RX ACCUNET EMBOLIC PROTECTION SYSTEM NFA NFA GUIDANT ENDOVASCULAR SOLUTIONS NA 6060551

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization| S STENT: RX ACCULINK