BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAROTID WALLSTENT MONORAIL

    MDR report key: 4231989 · Received November 6, 2014

    Report

    Report Number
    2134265-2014-06656
    Event Type
    Injury
    Date Received
    November 6, 2014
    Report Date
    October 13, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIM
    PMA / PMN Number
    P050019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ES
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. THE BATCH NUMBER IS UNKNOWN AND THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. THE ROOT CAUSE IS ANTICIPATED PROCEDURAL COMPLICATIONS AS THIS EVENT IS A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE AND IS NOTED WITHIN THE DFU. LITERATURE CITATION: JIMENEZ-GOMEZ, E. (2014). UNPROTECTED CAROTID ARTERY STENTING IN SYMPTOMATIC ELDERLY PATIENTS: A SINGLE-CENTER EXPERIENCE. JOURNAL OF NEUROINTERVENTIONAL SURGERY, 0:1-5. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A JOURNAL ARTICLE THAT PATIENT INJURY OCCURRED. PATIENTS WERE TREATED WITH CAROTID WALLSTENTS AND OTHER NON-BSC STENTS. DURING THE PROCEDURES, TWO PATIENTS EXPERIENCED TIA (TRANSIENT ISCHEMIC ATTACK) AND ONE PATIENT EXPERIENCED INTRAPARENCHYMAL HEMORRHAGE. FIVE PATIENTS EXPERIENCED TRANSIENT BRADYCARDIA RELATED TO CAROTID SINUS STIMULATION. WITHIN THE FIRST 30 DAYS OF STENT PLACEMENT, ON PATIENT EXPERIENCED AN ACUTE ISCHEMIC STROKE. AT THE ONE YEAR FOLLOW UP, TWO IPSILATERAL STROKES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714579 CAROTID WALLSTENT MONORAIL STENT, CAROTID NIM BOSTON SCIENTIFIC - GALWAY UNK60

    Patients

    Seq Age Sex Outcome Treatment
    1 Other