BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCULINK CAROTID STENT SYSTEM

    MDR report key: 2943653 · Received February 5, 2013

    Report

    Report Number
    2024168-2013-00621
    Event Type
    Injury
    Date Received
    February 5, 2013
    Date of Event
    May 29, 2012
    Report Date
    January 10, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIM
    PMA / PMN Number
    P040012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    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, INFECTION, AND TRANSIENT ISCHEMIC ATTACK (TIA) ARE KNOWN OBSERVED AND POTENTIAL ADVERSE EVENTS 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. DATE OF EVENT ESTIMATED BASED ON DATE OF PUBLICATION. DATE OF IMPLANT ESTIMATE BASED ON DATE OF PUBLICATION. THE XACT REFERENCED IS BEING FILED UNDER A SEPARATE MANUFACTURING REPORT NUMBER. PROSPECTIVE, MULTICENTER EUROPEAN STUDY OF THE GORE FLOW REVERSAL SYSTEM FOR PROVIDING NEUROPROTECTION DURING CAROTID ARTERY STENTING, PAGES 1060 TO 1068.

    Description of Event or Problem · 1

    THIS EVENT WAS CAPTURED BASED ON AN ARTICLE REVIEW: BACKGROUND: EMBOLIC PROTECTION DEVICES (EPDS) ARE USED TO PROVIDE PROTECTION AGAINST BRAIN EMBOLIZATION DURING CAROTID ARTERY STENTING (CAS) TO TREAT CAROTID ARTERY STENOSIS, BUT THE OPTIMAL TYPE OF EPD HAS NOT BEEN DETERMINED. DISTALLY POSITIONED FILTERS ARE COMMONLY USED BUT DO NOT PROVIDE PROTECTION DURING CROSSING OF THE LESION. THIS PROSPECTIVE, MULTICENTER STUDY INVESTIGATED A PROXIMALLY PLACED DEVICE (GORE FLOW REVERSAL SYSTEM) THAT REVERSES BLOOD FLOW IN THE INTERNAL CAROTID ARTERY DURING CAS, THEREBY DIRECTING EMBOLI AWAY FROM THE BRAIN. METHODS AND RESULTS: OUTCOMES IN 122 PATIENTS (28% SYMPTOMATIC), WHO UNDERWENT CAS USING THE FLOW REVERSAL SYSTEM WERE ASSESSED (INTENTION-TO-TREAT ANALYSIS). THE PRIMARY ENDPOINT WAS A MAJOR ADVERSE EVENT WITHIN 30 DAYS OF CAS. THE SECONDARY ENDPOINT WAS A MYOCARDIAL INFARCTION (MI) OR NONSTROKE-RELATED NEUROLOGIC EVENT WITHIN 30 DAYS. THE FLOW REVERSAL SYSTEM COULD NOT BE USED IN ONE PATIENT BECAUSE OF SEVERE VESSEL TORTUOSITY AND IN TWO PATIENTS (1.6%) BECAUSE OF INTOLERANCE. THE 30-DAYS MAE RATE AND THE SECONDARY ENDPOINT RATE WERE EACH 1.6%. NO PATIENT IN THE SERIES DIED OR HAD A MI WITHIN 30 DAYS. NO PATIENT WHO WAS SYMPTOMATIC BEFORE CAS HAD AN MAE. ONE SYMPTOMATIC AND ONE ASYMPTOMATIC PATIENT HAD A TRANSIENT ISCHEMIC ATTACK. CONCLUSIONS: USE OF THE GORE FLOW REVERSAL SYSTEM DURING CAS HAD A HIGH RATE OF TECHNICAL SUCCESS AND LOW 30-DAY RATES OF ADVERSE NEUROLOGIC AND CARDIAC EVENTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49212 ACCULINK CAROTID STENT SYSTEM CAROTID STENT SYSTEM NIM AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R| S