BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RX ACCULINK CAROTID STENT SYSTEM

    MDR report key: 2964223 · Received February 15, 2013

    Report

    Report Number
    2024168-2013-00912
    Event Type
    Injury
    Date Received
    February 15, 2013
    Date of Event
    January 9, 2013
    Report Date
    January 21, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIM
    PMA / PMN Number
    P040012
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, 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. IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT HANDLING DATABASE FOR THIS LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE REVIEWED INFORMATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED. THE REPORTED PATIENT EFFECTS OF BRADYCARDIA, CEREBROVASCULAR ACCIDENT, NEUROLOGICAL DEFICIT DYSFUNCTION, HYPOTENSION, AND VISUAL DISTURBANCES, AS LISTED IN THE ADVERSE EVENTS SECTION OF THE ACCULINK CAROTID STENT SYSTEM INSTRUCTIONS FOR USE, ARE KNOWN ADVERSE EVENTS ASSOCIATED WITH CAROTID STENTING PROCEDURES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2012, AN ACCULINK STENT WAS IMPLANTED IN A DE NOVO, MODERATELY CALCIFIED, 70% STENOSED, RIGHT INTERNAL CAROTID ARTERY AND APPROXIMATELY 15 MONTHS LATER, THE PATIENT EXPERIENCED RIGHT FOOT WEAKNESS, VERBAL DIFFICULTIES, VISUAL DISTURBANCES, AND WAS DIAGNOSED WITH AN ACUTE STROKE OF THE RIGHT OCCIPITAL REGION. AN AREA OF THE ACCULINK STENT WAS FOUND UNEXPANDED ON THE ANGIOGRAM. A BALLOON DILATION ANGIOPLASTY WAS PERFORMED TO THE UNEXPANDED REGION OF THE PROXIMAL STENT ON (B)(6) 2013. AFTER THE BALLOON DILATATION THE PATIENT EXPERIENCED BRADYCARDIA AND HYPOTENSION WHICH RESOLVED WITH COMMON MEDICATIONS, ATROPINE, DOPAMINE, AND NEO-SYNEPHRINE WITHIN 24 HOURS. AFTER THE ANGIOPLASTY, THE STENT WAS WIDELY PATENT WITH THE RESIDUAL NARROWING AT THE SITE OF THE STENT LESS THAN 30%. THERE WAS NO EVIDENCE OF DISSECTION OR LIMITATION OF FLOW AND NO DISTAL EMBOLIZATION. THE RIGHT FOOT WEAKNESS, VERBAL DIFFICULTIES, VISUAL DISTURBANCES SYMPTOMS ARE LISTED AS CHRONIC WITH A PATIENT SEQUELA. THE PATIENT WAS DISCHARGED ON (B)(6) 2013. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69013 RX ACCULINK CAROTID STENT SYSTEM CAROTID STENT SYSTEM NIM AV-TEMECULA-CT 2061961

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| R| S