BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTEGE RX CAROTID STENT SYSTEM

    MDR report key: 7115369 · Received December 13, 2017

    Report

    Report Number
    2183870-2017-00570
    Event Type
    Injury
    Date Received
    December 13, 2017
    Date of Event
    June 23, 2017
    Report Date
    December 13, 2017
    Manufacturer
    COVIDIEN
    Product Code
    NIM
    PMA / PMN Number
    P060001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE/DATE OF BIRTH: MEAN AGE OF PATIENT COHORT. SEX: 68.7% OF PATIENT COHORT WAS MALE. DATE OF EVENT: LITERATURE ARTICLE PUBLISHED DATE LONG-TERM RESULTS OF TAPERED STENTS IN ENDOVASCULAR TREATMENT OF CAROTID STENOSIS ANN VASC SURG 2017; 45: 79¿84 HTTP://DX.DOI.ORG/10.1016/J.AVSG.2017.06. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE JOURNAL ARTICLE EXPLORES A STUDY AIMING TO INVESTIGATE THE IMPACT OF STENT CONFIGURATION (TAPERED STENTS VS STRAIGHT STENTS) ON PERIOPERATIVE AND LONG-TERM RESULTS IN ENDOVASCULAR TREATMENT OF CAROTID STENOSIS. DURING THE STUDY PERIOD, 1368 CAROTID ARTERY STENTING (CAS) PROCEDURES WERE PERFORMED AT THE FACILITY. THE MEAN AGE OF THE PATIENT COHORT WAS 71 YEARS AND 940 PATIENTS WERE MALE (68.7 %). IN 485 CASES, TAPERED STENTS, INCLUDING PROTÉGÉ AND CRISTALLO IDEALE WERE USED WHILE IN 883 CASES CYLINDRICAL STENTS INCLUDING EXPONENT WERE USED. DURING THE FOLLOW UP PERIOD, TIA OCCURRED IN 39 PATIENTS AND 20 PATIENTS SUFFERED STROKES. CASES OF RESTENOSIS WERE ALSO RECORDED. IMMEDIATE CONVERSION TO CAROTID ENDARTERECTOMY WITH STENT REMOVAL WAS NECESSARY IN 4 CASES FOR STENT OCCLUSION OR MALPOSITION OF THE STENT. THE STUDY CONCLUDED THAT THE USE OF CONIC STENTS APPEARS TO BE ASSOCIATED WITH SIMILAR PERIOPERATIVE RESULTS WHEN COMPARED WITH THE STRAIGHTS STENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    892553 PROTEGE RX CAROTID STENT SYSTEM STENT, CAROTID NIM COVIDIEN

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention