BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTEGE RX CAROTID STENT SYSTEM

    MDR report key: 7365922 · Received March 23, 2018

    Report

    Report Number
    2183870-2018-00150
    Event Type
    Injury
    Date Received
    March 23, 2018
    Date of Event
    October 20, 2017
    Report Date
    March 23, 2018
    Manufacturer
    COVIDIEN
    Product Code
    NIM
    PMA / PMN Number
    P060001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AVERAGE AGE, MAJORITY GENDER,EVENT DATE IS LITERATURE ARTICLE PUBLISHED ONLINE DATE   RECURRENT STENOSIS FOLLOWING CAROTID ARTERY STENTING TREATED WITH A DRUG-ELUTING BALLOON: A SINGLE-CENTER RETROSPECTIVE ANALYSIS C. POHLMANN & J. HÖLTJE & M. ZEILE & F. BONK & P. P. URBAN & R. BRÜNING NEURORADIOLOGY (2018) 60:81¿87 DOI.ORG/10.1007/S00234-017-1935-7. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE JOURNAL DOCUMENTS A RETROSPECTIVE SINGLE CENTER ANALYSIS OF PATIENTS WITH CAROTID ARTERY STENTING BETWEEN 2009 AND 2015. NINE PATIENTS WITH HIGH-GRADE CAROTID ARTERY IN STENT RESTENOSIS WERE IDENTIFIED. IN THE ORIGINAL INDEX PROCEDURES, ALL PATIENTS HAD CAROTID ARTERY STENTING CARRIED OUT. A PROTEGE CAROTID STENT WAS USED IN ONE PATIENT WHILE NON-MDT DEVICES WERE USED IN THE OTHER EIGHT PATIENTS. RESTENOSIS OCCURRED IN ALL PATIENTS POST PROCEDURE. ALL NINE PATIENTS WERE THEN RETREATED USING DRUG ELUTING BALLOONS. MEDTRONIC IN.PACT AMPHIPRION BALLOONS WERE USED IN FIVE OF THESE PROCEDURES. RESTENOSIS OCCURRED IN ONE PATIENT DURING THE FOLLOW UP PERIOD POST DEB TREATMENT. THERE WERE NO PRODUCT PROBLEMS AND NO OTHER ADVERSE EVENTS REPORTED IN CASES WHERE A MEDTRONIC DEVICE WAS USED. TWO DEATHS OCCURRED DURING THE FOLLOW UP PERIOD: ONE DECEASED DUE TO A BRONCHIAL CARCINOMA AND THE OTHER DECEASED DUE TO UROSEPSIS. BOTH DEATHS WERE UNRELATED TO THE DEB TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    210554 PROTEGE RX CAROTID STENT SYSTEM STENT, CAROTID NIM COVIDIEN

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention