BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTEGE RX CAROTID STENT SYSTEM

    MDR report key: 12224813 · Received July 26, 2021

    Report

    Report Number
    2183870-2021-00255
    Event Type
    Injury
    Date Received
    July 26, 2021
    Date of Event
    January 7, 2021
    Report Date
    July 26, 2021
    Manufacturer
    COVIDIEN
    Product Code
    NIM
    PMA / PMN Number
    P060001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    JOURNAL ARTICLE TITLE: EFFICACY OF PRETREATMENT WITH THE FREE RADICAL SCAVENGER, EDARAVONE, FOR PREVENTION OF CEREBRAL HYPERPERFUSION AFTER CAROTID ARTERY STENTING: A SINGLE-CENTER RANDOMIZED CONTROLLED TRIAL INTERDISCIPLINARY NEUROSURGERY VOLUME 24, JUNE 2021, 101092 HTTPS://DOI.ORG/10.1016/J.INAT.2021.101092. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS SUBMITTED DETAILING A STUDY TO DETERMINE WHETHER PRE-TREATMENT WITH A FREE RADICAL SCAVENGER, EDARAVONE, COULD PREVENT CEREBRAL HYPERPERFUSION (CHP) AFTER CAROTID ARTERY STENTING (CAS). MEDTRONIC¿S PROTEGE RX SELF-EXPANDING STENT WAS USED IN THE STUDY. 52 PATIENTS WERE SPLIT EQUALLY BETWEEN THE EDARAVONE GROUP AND CONTROL GROUP. THE TRIAL WAS STOPPED AHEAD OF SCHEDULE DUE TO POOR RECRUITMENT. AMONG 52 PARTICIPANTS, 51 COMPLETED THE TRIAL; 25 IN THE EDARAVONE GROUP, AND 26 IN THE CONTROL GROUP. THE PRIMARY OUTCOME WAS OCCURRENCE OF CHP IMMEDIATELY AFTER CAS. THE SECONDARY OUTCOMES INCLUDED POST-CAS CBF, POST-CAS AI, POST-CAS MCA-TO-CEREBELLAR ACTIVITY RATIO, CBF CHANGE, AI CHANGE, AND MCA-TO CEREBELLAR ACTIVITY RATIO CHANGE. ONE PATIENT IN THE EDARAVONE GROUP COULD NOT UNDERGO SINGLE-PHOTON EMISSION COMPUTED TOMOGRAPHY (SPECT) AFTER CAS DUE TO AN EMBOLIC COMPLICATION DURING CAS. PERIOPERATIVE COMPLICATIONS OCCURRED IN 3 PATIENTS, 2 HAD ISCHEMIC STROKE OR TRANSIENT ISCHEMIC ATTACK, AND ONE PATIENT HAD RETROPERITONEAL HEMORRHAGE CAUSED BY FEMORAL ARTERY PUNCTURE SITE BLEEDING. 3 PATIENTS HAD CHP INCLUDING ONE WITH TRANSIENT POSTPROCEDURAL HYPOTENSION, BUT THE PATIENT¿S HAD NO CLINICAL SYMPTOMS. THE AUTHOR CONCLUDED PRETREATMENT WITH EDARAVONE APPEARED NOT TO BE ASSOCIATED WITH REDUCTION IN THE OCCURRENCE OF CHP IMMEDIATELY AFTER CAS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1122708 PROTEGE RX CAROTID STENT SYSTEM STENT, CAROTID NIM COVIDIEN UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR