BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RX ACCULINK CAROTID STENT SYSTEM

    MDR report key: 3170643 · Received June 14, 2013

    Report

    Report Number
    2024168-2013-03733
    Event Type
    Injury
    Date Received
    June 14, 2013
    Date of Event
    May 17, 2013
    Report Date
    May 21, 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 BRADYCARDIA AND HYPOTENSION ARE KNOWN OBSERVED AND POTENTIAL PATIENT EFFECTS AS LISTED IN THE RX ACCULINK CAROTID STENT SYSTEM ELECTRONIC 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 AFTER AN ACCULINK STENT WAS IMPLANTED IN THE LEFT INTERNAL CAROTID ARTERY, DURING POST-DILATATION, THE PATIENT EXPERIENCED HYPOTENSION AND DOPAMINE MEDICATION WAS GIVEN. POST-PROCEDURE, THE SAME DAY, THE PATIENT EXPERIENCED BRADYCARDIA WITH A PULSE DOWN IN THE 40'S BEATS PER MINUTE RANGE. ATROPINE WAS GIVEN FOR THE BRADYCARDIA. BOTH THE BRADYCARDIA AND THE HYPOTENSION RESOLVED WITHOUT AN ADVERSE PATIENT SEQUELA ON (B)(6) 2013, BUT BOTH OF THE EVENTS WERE REPORTED AS SERIOUS AND THERE WAS A PROLONGED HOSPITALIZATION OCCURRENCE. THE PATIENT WAS DISCHARGED HOME ON (B)(6) 2013. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270835 RX ACCULINK CAROTID STENT SYSTEM CAROTID STENT SYSTEM NIM AV-TEMECULA-CT 1080361

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| R EMBOLIC PROTECTION: EMBOSHIELD NAV6