BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTEGE RX CAROTID STENT SYSTEM

    MDR report key: 6543318 · Received May 4, 2017

    Report

    Report Number
    2183870-2017-00197
    Event Type
    Injury
    Date Received
    May 4, 2017
    Date of Event
    May 24, 2016
    Report Date
    April 5, 2017
    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

    MEAN AGE BLOCK, MEAN GENDER STUDY TITLE: COMPLICATIONS AND PREDICTORS OF HYPOTENSION REQUIRING VASOPRESSOR AFTER CAROTID ARTERY STENTING MASATAKA NANTO, YUDAI GOTO, HIROYUKI YAMAMOTO, SEISUKE TANIGAWA, HAYATO TAKEUCHI, YOSHIKAZU NAKAHARA, HIROSHI TENJIN, AND MICHIKO TAKADO DOI: 10.2176/NMC.OA.2016-0155. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE STUDY RETROSPECTIVELY ANALYZED THE MEDICAL RECORDS OF (B)(4) CASES WHO UNDERWENT CAS FOR SYMPTOMATIC AND ASYMPTOMATIC CAROTID ARTERY STENOSIS. AMONG THEM, FOUR CASES WHO SUFFERED PROGRESSIVE STROKE AND WERE TREATED IN THE ACUTE PHASE WERE EXCLUDED FROM THIS STUDY. FINALLY (B)(4) CASES WERE INCLUDED IN THIS RETROSPECTIVE STUDY. PATIENTS WERE TREATED WITH CLOSED CELL STENTS AND OPEN CELL STENTS INCLUDING PROTÉGÉ STENTS. IT IS REPORTED THAT 30-DAY STROKE OCCURRED IN SIX CASES. NEW ISCHEMIC LESIONS DETECTED ON POSTPROCEDURAL DW-MRI WERE OBSERVED IN (B)(4) CASES OF THE HG GROUP AND (B)(4) CASES OF THE NHG. IT IS REPORTED THAT PATIENT DEATH OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    327599 PROTEGE RX CAROTID STENT SYSTEM STENT, CAROTID NIM COVIDIEN

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization