BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RX ACCULINK CAROTID STENT SYSTEM

    MDR report key: 1842111 · Received September 20, 2010

    Report

    Report Number
    3004742046-2010-00430
    Event Type
    Injury
    Date Received
    September 20, 2010
    Date of Event
    August 26, 2010
    Report Date
    August 26, 2010
    Manufacturer
    ABBOTT VASCULAR-VASCULAR SOLUTIONS
    Product Code
    NIM
    PMA / PMN Number
    P040038
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED PATIENT EFFECT OF NEUROLOGICAL DEFICIT/DYSFUNCTION IS A KNOWN ADVERSE EVENT AS LISTED IN THE PRODUCTS INSTRUCTION FOR USE. 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 THAT POST STENT IMPLANTATION IN THE LEFT INTERNAL CAROTID ARTERY, THE PATIENT'S NIHSS SCORE CHANGED FOR LEVEL OF CONSCIOUSNESS (LOC). PRE-PROCEDURE, THE PATIENT COULD ANSWER 2 LOC QUESTIONS. POST PROCEDURE, ONLY 1 QUESTION WAS CORRECTLY ANSWERED. THE CAUSE OF THE CHANGE IN LOC WAS NOT PROVIDED. THE CONDITION IS CONTINUING UNCHANGED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION 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 9012251

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Disability EMBOLIC PROTECTION: RX ACCUNET