BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RX ACCULINK CAROTID STENT SYSTEM

    MDR report key: 924471 · Received October 8, 2007

    Report

    Report Number
    3004742046-2007-00306
    Event Type
    Injury
    Date Received
    October 8, 2007
    Report Date
    September 13, 2007
    Manufacturer
    ABBOTT VASCULAR-VASCULAR SOLUTIONS
    Product Code
    NIM
    PMA / PMN Number
    P040012
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ATTACHMENT: NIKOLAS SARATZIS, ET AL. CAROTID ARTERY STENT PLACEMENT WITH EMBOLIC PROTECTION: SINGLE-CENTER EXPERIENCE. J VASC INTERV RADIOL 2007; 18:337-342. THE DEVICE IS NOT RETURNING. THE LOT NUMBER WAS NOT IDENTIFIED; THEREFORE, A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED. (SEE SCANNED PAGES).

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: NONE. SYMPTOMS/AE: MINOR NEUROLOGICAL COMPLICATIONS. TIME OF SYMPTOMS: POSTOPERATIVELY. THE FOLLOWING EVENT WAS NOTED DURING LITERATURE REVIEW: A PATIENT EXPERIENCED REVERSIBLE MINOR NEUROLOGICAL COMPLICATIONS DESCRIBED AS MOTOR ARM DEFICIT AND WAS HOSPITALIZED FOR CLOSE SURVEILLANCE UNTIL THE NEUROLOGICAL COMPLICATIONS HAD COMPLETELY RESOLVED. THERE WERE NO FINDINGS ON THE CT SCAN OF THE BRAIN AND THE PATIENT WAS DISCHARGED ONE WEEK LATER. NO ISSUES WITH THE DEVICES WERE REPORTED. THOUGH REQUESTED NO ADDITIONAL INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RX ACCULINK CAROTID STENT SYSTEM NIM ABBOTT VASCULAR-VASCULAR SOLUTIONS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Hospitalization 8-F GUIDING CATHETER (VIKING)| ATROPINE| RX ACCUNET| HEPARIN| 8-F SHEATH (AXCESS)| POST DILATION| BALLOONS 5-6 MM IN DIA 20 MM LONG (GUIDANT)