BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RX ACCULINK CAROTID STENT SYSTEM

    MDR report key: 1251322 · Received December 3, 2008

    Report

    Report Number
    3004742046-2008-00294
    Event Type
    Injury
    Date Received
    December 3, 2008
    Date of Event
    October 15, 2008
    Report Date
    November 13, 2008
    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
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    STUDY EVENT. THE DEVICE REMAINS IN THE PT. THE LOT NUMBER WAS PROVIDED. REVIEW OF THE DEVICE HISTORY RECORD DID NOT REVEAL ANY NON-CONFORMITIES, WHICH COULD HAVE CONTRIBUTED TO THE COMPLAINT. STROKE MAY OCCUR DURING THIS TYPE OF PROCEDURE AND AS LISTED IN THE DEVICE INSTRUCTIONS FOR USE. STROKE IS A KNOWN POSSIBLE ADVERSE EVENT ASSOCIATED WITH THE USE OF CAROTID STENTS. THE REPORTED HOSPITALIZATION WAS IN RESPONSE TO THE OBSERVED PT EFFECTS. IN ADDITION, NO DEVICE MALFUNCTION WAS REPORTED.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: NONE. TIME OF SYMPTOMS/AE: POST PROCEDURE. SYMPTOMS/AE: STROKE. IT WAS REPORTED THAT AFTER A RIGHT INTERNAL CAROTID ARTERY STENTING PROCEDURE THE PT EXPERIENCED A STROKE WITH LEFT SIDED WEAKNESS, SUBTLE LEFT FACIAL DROOP, AND VISUAL HEMINEGLECT/HEMIANOPIA. A CT SCAN OF THE HEAD AND AN EEG WAS ORDERED REVEALING A NEW LESION IN THE RIGHT PARIETAL WHITE MATTER, WHICH WAS FELT TO BE ON THE BASIS OF CHRONIC ISCHEMIA AND POSSIBLY ACUTE. THE EEG REPORT WAS ABNORMAL SHOWING FOCAL NEURONAL DISTURBANCES SEEN OVER THE RIGHT TEMPORAL HEAD REGIONS. THE PT WAS DISCHARGED TO HOME 6 DAYS POST PROCEDURE AND THE CONDITION WAS REPORTED AS CONTINUING BUT IMPROVING. THE 30 DAY F/U VISIT REVEALED MINOR PARALYSIS IN FACIAL PARESIS AND ALL OTHER AREAS WERE RECOVERED AND MARKED AS NORMAL. THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RX ACCULINK CAROTID STENT SYSTEM NIM ABBOTT VASCULAR-VASCULAR SOLUTIONS NA 8082751

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| S RX ACCUNET EPD| BIVALIRUDIN