BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RX ACCULINK CAROTID STENT SYSTEM

    MDR report key: 1955435 · Received January 10, 2011

    Report

    Report Number
    2024168-2011-00209
    Event Type
    Injury
    Date Received
    January 10, 2011
    Date of Event
    December 15, 2010
    Report Date
    December 16, 2010
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIM
    PMA / PMN Number
    P040038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED PATIENT EFFECTS OF CEREBROVASCULAR ACCIDENT AND VISUAL DISTURBANCES ARE KNOWN ADVERSE EVENTS LISTED IN THE RX ACCULINK INSTRUCTIONS FOR USE. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE, DESIGN, OR LABELING.

    Additional Manufacturer Narrative · 1

    (B)(4). EMBOLIC PROTECTION: RX ACCUNET (1011649-65/0010361). THE STENT REMAINS IN THE PATIENT. A FOLLOW-UP WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    THE PATIENT WAS DISCHARGED TO HOME ON (B)(6) 2010.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA TRIAL THAT ONE DAY AFTER THE IMPLANTATION OF ACCULINK STENT IN THE RIGHT INTERNAL CAROTID ARTERY, THE PATIENT EXPERIENCED A POSSIBLE STROKE WITH BLURRED VISION AND DIFFICULTY SEEING. THERE WERE NO OTHER NEUROLOGICAL SYMPTOMS REPORTED. THERE WAS NO REPORTED INTERVENTION. THE PATIENT'S CONDITION HAS IMPROVED, BUT IS CONTINUING. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RX ACCULINK CAROTID STENT SYSTEM CAROTID STENT SYSTEM NIM AV-TEMECULA-CT 0092161

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| S