BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RX ACCULINK CAROTID STENT SYSTEM

    MDR report key: 2880576 · Received December 19, 2012

    Report

    Report Number
    2024168-2012-08190
    Event Type
    Injury
    Date Received
    December 19, 2012
    Date of Event
    November 16, 2012
    Report Date
    December 5, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIM
    PMA / PMN Number
    P040012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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, HYPOTENSION, INTRACRANIAL HEMORRHAGE, AND NEUROLOGICAL DEFICIT DYSFUNCTION ARE KNOWN OBSERVED AND POTENTIAL ADVERSE EVENTS AS LISTED IN THE RX ACCULINK CAROTID STENT SYSTEM ELECTRONIC INSTRUCTIONS FOR USE (IFU). 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 DURING A LEFT INTERNAL CAROTID ARTERY STENTING PROCEDURE, THE PATIENT EXPERIENCED BRADYCARDIA AND HYPOTENSION. THE BRADYCARDIA WAS TREATED WITH ATROPINE AND THE HYPOTENSION WAS TREATED WITH DOPAMINE AND PSEUDOEPHEDRINE. ON (B)(6) 2012, THE HYPOTENSION RESOLVED. ON (B)(6) 2012, THE PATIENT WAS DISCHARGED HOME. BRADYCARDIA WAS NOTED AS CONTINUING. ON (B)(6) 2012, THE PATIENT WOKE UP WITH BLURRING LEFT EYE VISION AND CONFUSION. ON (B)(6) 2012, A LEFT PARIETAL HEMORRHAGE WAS CONFIRMED PER CT SCAN AND THE PATIENT WAS HOSPITALIZED. ASPIRIN AND PLAVIX WERE HELD. ON (B)(6) 2012, THE PATIENT WAS DISCHARGED WITH SYMPTOMS CONTINUING. ON (B)(6) 2012, THE BRADYCARDIA WAS NOTED AS RESOLVED. 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 2022461

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| R| S EMBOLIC PROTECTION: RX ACCUNET