BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RX ACCULINK CAROTID STENT SYSTEM

    MDR report key: 3190439 · Received June 26, 2013

    Report

    Report Number
    2024168-2013-03987
    Event Type
    Injury
    Date Received
    June 26, 2013
    Date of Event
    December 19, 2012
    Report Date
    June 5, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIM
    PMA / PMN Number
    P040012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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 EFFECTS OF CEREBROVASCULAR ACCIDENT AND EMBOLISM ARE KNOWN OBSERVED AND POTENTIAL PATIENT EFFECTS AS LISTED IN THE RX ACCULINK CAROTID STENT SYSTEM INSTRUCTIONS FOR USE. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURING, DESIGN OR LABELING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A 7-10X30 RX ACCULINK STENT WAS IMPLANTED IN THE MODERATELY CALCIFIED, RIGHT INTERNAL CAROTID ARTERY FOR TREATMENT OF A DE NOVO LESION. PRE-STENOSIS WAS 85%, POST-STENOSIS WAS 20%. FOLLOWING THE PROCEDURE SAME DAY, THE PATIENT EXPERIENCED RIGHT HAND NUMBNESS AND BLURRY VISION. SMALL ACUTE EMBOLIC STROKE WAS DIAGNOSED. TREATMENT CONSISTED OF HOSPITAL STAY AND ADMINISTRATION OF PHENYLEPHRINE. THE PATIENT WAS DISCHARGED HOME TWO DAYS POST PROCEDURE AND THE CONDITION RESOLVED WITHOUT SEQUELA (B)(6) 2013. NO ADDITIONAL INFORMATION WAS PROVIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291220 RX ACCULINK CAROTID STENT SYSTEM CAROTID STENT SYSTEM NIM AV-TEMECULA-CT 2082261

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| R| S EMBOLIC PROTECTION: EMBOSHIELD NAV6