BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAROTID WALLSTENT MONORAIL

    MDR report key: 4848395 · Received June 16, 2015

    Report

    Report Number
    2134265-2015-03602
    Event Type
    Injury
    Date Received
    June 16, 2015
    Report Date
    May 19, 2015
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIM
    PMA / PMN Number
    P050019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LITERATURE CITATION: CSOBAY-NOVAK , CSABA ET. AL. (2015) "ROLE OF STENT SELECTION IN THE INCIDENCE OF PERSISTING HEMODYNAMIC DEPRESSION AFTER CAROTID ARTERY STENTING" JOURNAL OF ENDOVASCULAR THERAPY, VOL. 22(I) 122-129. DEVICE EVALUATED BY MFR: THE DEVICE WAS NOT RETURNED FOR ANALYSIS. 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 IN THE DFU. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE THAT PATIENT COMPLICATIONS OF HYPOTENSION, BRADYCARDIA, PHD (PERSISTING HEMODYNAMIC DEPRESSION) AND ASYSTOLE WERE REPORTED. PACEMAKER IMPLANT REQUIRED FOR PATIENTS WHEN THEIR BRADYCARDIA DID NOT RESPOND TO WITHDRAWAL OF MEDICATIONS OR OTHER THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391611 CAROTID WALLSTENT MONORAIL STENT, CAROTID NIM BOSTON SCIENTIFIC - GALWAY UNK60

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention