BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RX ACCULINK CAROTID STENT SYSTEM

    MDR report key: 1912599 · Received December 2, 2010

    Report

    Report Number
    3004742046-2010-00570
    Event Type
    Injury
    Date Received
    December 2, 2010
    Date of Event
    November 8, 2010
    Report Date
    November 10, 2010
    Manufacturer
    AV-TEMECULA
    Product Code
    NIM
    PMA / PMN Number
    P040038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NEUROLOGICAL EVENT MAY OCCUR DURING THIS TYPE OF PROCEDURE AND AS LISTED IN THE INSTRUCTIONS FOR USE, NEUROLOGICAL EVENT IS A KNOWN OBSERVED ADVERSE EVENT ASSOCIATED WITH THE USE OF THE PRODUCT. THE REPORTED HOSPITALIZATION WAS IN RESPONSE TO THE PATIENT SYMPTOM. THERE WAS NO DEVICE MALFUNCTION REPORTED THAT COULD HAVE CONTRIBUTED TO THE EVENT. BASED ON AVAILABLE INFORMATION, A DEFINITIVE CAUSE FOR THE REPORTED PATIENT ADVERSE EFFECT AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED, HOWEVER, THERE WAS NO INDICATION OF ANY PRODUCT DEFICIENCIES WHICH COULD HAVE CONTRIBUTED TO THE OUTCOME OF THE PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 2 WEEKS POST ACCULINK STENT IMPLANTATION, THE PATIENT PRESENTED WITH SYMPTOMS OF CEREBRAL VASCULAR ACCIDENT (CVA). AN ACCULINK STENT WAS IMPLANTED ON (B)(6) 2010 IN THE LEFT INTERNAL CAROTID ARTERY, USING A NAV 6 FILTER FOR EMBOLIC PROTECTION. PRE-DILATATION AND POST-DILATATION WERE PERFORMED WITH VIATRAC BALLOONS. THE PROCEDURE WAS SUCCESSFUL AND UNEVENTFUL. THE PATIENT RETURNED ON (B)(6) 2010 PRESENTING WITH RIGHT ARM WEAKNESS AND SYMPTOMS OF A CVA. A CT ANGIOGRAPHY WAS PERFORMED WHICH SHOWED NO CEREBRAL DAMAGE OR BLOCKAGE. THE STENT WAS PATENT AND WELL OPPOSED. THE PHYSICIAN WAS CONCERNED WITH THE PATIENT'S PLAVIX AND ASPIRIN COMPLIANCE AND HIGHER DOSES WERE PRESCRIBED. THE PATIENT WAS EVALUATED BY A NEURO SURGEON WHO BELIEVES THIS MAY BE CAUSED BY HER PREVIOUS MICROVASCULAR DISEASE. (THE PATIENT HAD A PREVIOUS TRANSIENT ISCHEMIC ATTACK (TIA) PRIOR TO THE INITIAL PROCEDURE.) THE PATIENT'S SYMPTOMS RESOLVED AND SHE WAS DISCHARGED FROM THE HOSPITAL THE NEXT DAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RX ACCULINK CAROTID STENT SYSTEM CAROTID STENT SYSTEM NIM AV-TEMECULA 0092162

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| S VIATRAC 4.0X20,5.5X30EMBOSHIELD NAV 6