BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RX ACCULINK CAROTID STENT SYSTEM

    MDR report key: 2615188 · Received June 13, 2012

    Report

    Report Number
    2024168-2012-03781
    Event Type
    Injury
    Date Received
    June 13, 2012
    Date of Event
    May 21, 2012
    Report Date
    May 22, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIM
    PMA / PMN Number
    P040012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL DEVICES: CLOPIDOGREL, ASPIRIN; EMBOLIC PROTECTION: RX ACCUNET, 6.5 X 190 (1011649-65, LOT# 2020161). THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED PATIENT EFFECTS OF BRADYCARDIA AND HYPOTENSION ARE KNOWN OBSERVED AND POTENTIAL ADVERSE EVENTS AS LISTED IN THE RX ACCULINK CAROTID STENT SYSTEM INSTRUCTIONS FOR USE (IFU) IN THE POTENTIAL ADVERSE EVENT SECTION. 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 THE PROCEDURE IN THE MILDLY CALCIFIED LEFT INTERNAL CAROTID ARTERY ON (B)(6) 2012, THE 7-10 X 30 MM ACCULINK STENT SYSTEM WAS ADVANCED INTO THE PATIENT ANATOMY AND THE STENT WAS DEPLOYED. FOLLOWING STENT DEPLOYMENT, THE PATIENT EXPERIENCED AN EPISODE OF HYPOTENSION AND EXACERBATION OF PRE-EXISTING BRADYCARDIA. INTRAVENOUS ATROPINE AND DOPAMINE WERE ADMINISTERED TO TREAT THE HYPOTENSION AND BRADYCARDIA. THE HYPOTENSION RESOLVED THE FOLLOWING DAY; HOWEVER, THE BRADYCARDIA CONTINUED AND A PERMANENT PACEMAKER WAS IMPLANTED. THE BRADYCARDIA RESOLVED (B)(6) 2012. NO ADDITIONAL INFORMATION WAS 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 2012561

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention