BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RX ACCULINK CAROTID STENT SYSTEM

    MDR report key: 1973216 · Received January 28, 2011

    Report

    Report Number
    2024168-2011-00535
    Event Type
    Injury
    Date Received
    January 28, 2011
    Date of Event
    October 26, 2010
    Report Date
    January 7, 2011
    Product Code
    NIM
    PMA / PMN Number
    P040038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 REPORTED PRODUCT DEFICIENCY. THE REPORTED PATIENT EFFECT OF NEUROLOGICAL DEFICIT/DYSFUNCTION IS A KNOWN ADVERSE EVENT AS LISTED INSTRUCTION FOR USE. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT 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.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A TRIAL THAT DURING A LEFT INTERNAL CAROTID ARTERY STENTING PROCEDURE WITH A RX ACCULINK, THE PATIENT EXPERIENCED A TRANSIENT ISCHEMIC ATTACK WITH SPEECH DIFFICULTY AND VISUAL DISTURBANCE. THE SPEECH DIFFICULTY RESOLVED BY THE END OF THE PROCEDURE HOWEVER THE VISUAL DISTURBANCE PERSISTED UNTIL TWENTY ONE DAYS AFTER THE PROCEDURE. THERE WAS NO REPORTED TREATMENT PROVIDED. THE PATIENT WAS DISCHARGED ONE DAY AFTER THE PROCEDURE. THOUGH REQUESTED, 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 0092161

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Disability BIVALIRUDINEMBOLIC PROTECTION: RX ACCUNET