BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RX ACCULINK CAROTID STENT SYSTEM

    MDR report key: 2033038 · Received March 29, 2011

    Report

    Report Number
    2024168-2011-02141
    Event Type
    Injury
    Date Received
    March 29, 2011
    Date of Event
    February 5, 2011
    Report Date
    March 4, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIM
    PMA / PMN Number
    P040038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THERE WAS NO DEVICE MALFUNCTION REPORTED THAT COULD HAVE CONTRIBUTED TO THE EVENT. STROKE AND EMBOLISM MAY OCCUR DURING THIS TYPE OF PROCEDURE AND AS LISTED IN THE PRODUCT INSTRUCTIONS FOR USE, STROKE AND EMBOLISM ARE KNOWN POTENTIAL ADVERSE EVENTS ASSOCIATED WITH THE USE OF THE PRODUCT. ALTHOUGH A DEFINITIVE CAUSE FOR THE REPORTED PATIENT ADVERSE EFFECTS AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED, THERE WAS NO INDICATION OF A PRODUCT DEFICIENCY WHICH COULD HAVE CONTRIBUTED TO THE PATIENT EFFECTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ONE DAY AFTER THE IMPLANTATION OF THE ACCULINK STENT IN THE RIGHT INTERNAL CAROTID ARTERY, THE PATIENT EXPERIENCED A STROKE WITH LEFT UPPER EXTREMITY WEAKNESS. THERE WAS NO REPORTED INTERVENTION AND THE WEAKNESS GRADUALLY IMPROVED. THE MRI REVEALED AN EMBOLIC INFARCTION. THE PATIENT WAS TRANSFERRED TO A REHABILITATION FACILITY FIVE DAYS AFTER THE PROCEDURE. 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 0100561

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| S