BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RX ACCULINK CAROTID STENT SYSTEM

    MDR report key: 1970678 · Received January 25, 2011

    Report

    Report Number
    2024168-2011-00454
    Event Type
    Injury
    Date Received
    January 25, 2011
    Date of Event
    October 6, 2010
    Report Date
    January 4, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIM
    PMA / PMN Number
    P040038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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. STROKE MAY OCCUR DURING THIS TYPE OF PROCEDURE AND, AS LISTED IN THE INSTRUCTIONS FOR USE, STROKE IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE USE OF THE PRODUCT. BASED ON THE 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 VIA A TRIAL THAT AT THE END OF AN ACCULINK STENTING PROCEDURE IN THE LEFT INTERNAL CAROTID ARTERY, DURING THE REMOVAL OF THE CATHETERS FROM THE PATIENT'S ANATOMY, THE PATIENT EXPERIENCED A STROKE WITH RIGHT SIDED WEAKNESS, RIGHT FACIAL DROOP AND APHASIA. TREATMENT INCLUDED ANGIOMAX AND ACTIVASE. CT SCAN REVEALED ACUTE INFARCT TO LEFT MIDDLE CEREBRAL ARTERY. THE NEUROLOGIC DEFICITS CONTINUE, HOWEVER, THE PATIENT WAS DISCHARGED TO A REHABILITATION FACILITY SIX DAYS 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 AV-TEMECULA-CT 0062361

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Hospitalization| R| S BIVALIRUDIN, HEPARINRX ACCUNET EMBOLIC PROTECTIO