BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MO.MA

    MDR report key: 6489707 · Received April 13, 2017

    Report

    Report Number
    3004066202-2017-00040
    Event Type
    Injury
    Date Received
    April 13, 2017
    Report Date
    March 16, 2017
    Manufacturer
    INVATEC SPA
    Product Code
    NTE
    PMA / PMN Number
    K092177
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    INTRODUCTION: CAROTID ARTERY STENTING (CAS) IS AN ALTERNATIVE TREATMENT TO SURGICAL ENDARTERECTOMY IN SIGNIFICANT CAROTID ARTERY DISEASE. PROXIMAL PROTECTION DEVICES (PPD), ARE INCREASINGLY BEING USED FOR ACHIEVE CEREBRAL PROTECTION PRIOR TO CROSSING THE CAROTID STENOSIS. THIS STUDY EVALUATED THE SAFETY AND PERIOPERATIVE AND LONG-TERM EFFECTIVENESS IN PATIENTS WITH SIGNIFICANT CAROTID ARTERY STENOSIS TREATED WITH CAROTID STENTING AND PROXIMAL PROTECTION DEVICE (MEDTRONIC, (B)(4)) IN OUR CENTRE. METHODS: THIS PROSPECTIVE REGISTRY INCLUDED 125 PATIENTS (39.2% SYMPTOMATIC) WHO UNDERGONE CAS WITH PPD. THE EFFICACY WAS ASSESSED BY MEANS OF CUMULATIVE INCIDENCE OF ANY MAJOR ADVERSE EVENT (MAE) A COMPOSITE OF STROKE, MYOCARDIAL INFARCTION AND DEATH WITHIN 30 DAYS AFTER THE INTERVENTION OR IPSILATERAL STROKE AFTER 30 DAYS AND UP TO 4 YEARS. RESULTS: TECHNICAL SUCCESS WAS ACHIEVED IN 98.4% OF PROCEDURES. DURING THE PERIPROCEDURAL PERIOD (30 DAYS), THE INCIDENCE OF MAE WAS 1.6% ONE STROKE AND ONE DEATH, NOT RELATED WITH THE PROCEDURE. NO MYOCARDIAL INFARCTION WAS REPORTED. NO LONG-TERM IPSILATERAL STROKE OR NEUROLOGICAL DEATH WAS REPORTED. PROXIMAL ENDOVASCULAR OCCLUSION WAS WELL TOLERATED BY ALL OF THE PATIENTS. MINOR COMPLICATIONS INCLUDED 5 CASES (4%) OF TRANSIENT DISTAL SPASM OF INTERNAL CAROTID ARTERY (ALL OF THEM REASSUMED THEIR BASAL DIAMETER SPONTANEOUSLY WITHOUT LEADING TO ANY COMPLICATION) AND 1 CASE (0.8%) OF EXTERNAL CAROTID ARTERY THROMBOSIS. THERE WAS NO SIGNIFICANT DIFFERENCE IN THE RATES OF CUMULATIVE INCIDENCE OF MAE AT 30 DAYS BETWEEN SYMPTOMATIC AND ASYMPTOMATIC PATIENTS (0% VERSUS 2.6%; P¼0.52), NEITHER IN THE COMPONENTS, (STROKE 0% VERSUS1.3%; P¼0.6); AND DEATH (1.3% VERSUS 0%; P¼0.6). CONCLUSION: CAROTID ARTERY STENTING (CAS) WITH PROXIMAL PROTECTION DEVICE SEEMED EFFECTIVE AND SAFE IN OUR EXPERIENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272426 MO.MA CATHETER, CAROTID, TEMPORARY, FOR EMBOLIZATION CAPTURE NTE INVATEC SPA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention