BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RX ACCULINK CAROTID STENT SYSTEM

    MDR report key: 1980759 · Received February 7, 2011

    Report

    Report Number
    2024168-2011-00734
    Event Type
    Injury
    Date Received
    February 7, 2011
    Date of Event
    October 29, 2010
    Report Date
    January 13, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIM
    PMA / PMN Number
    P040038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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 EFFECT OF ARRHYTHMIA IS LISTED IN THE PRODUCT INSTRUCTION FOR USE AS A KNOWN POTENTIAL ADVERSE EFFECT ASSOCIATED WITH CAROTID PROCEDURES. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED; THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE OR DESIGN.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A TRIAL THAT ONE DAY AFTER A RIGHT INTERNAL CAROTID ARTERY STENTING PROCEDURE WITH A RX ACCULINK STENT, THE PATIENT EXPERIENCED PERSISTENT BRADYCARDIA HIGH-GRADE AV BLOCK WHICH REQUIRED A SINGLE-CHAMBER PACEMAKER IMPLANTATION. THE PATIENT'S CONDITION RESOLVED AND THE PATIENT WAS DISCHARGED HOME SIX DAYS AFTER THE PROCEDURE. 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 9061651

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Hospitalization| R BIVALIRUDINEMBOLIC PROTECTION: RX ACCUNET