BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAROTID WALLSTENT

    MDR report key: 8024995 · Received October 31, 2018

    Report

    Report Number
    2134265-2018-62462
    Event Type
    Malfunction
    Date Received
    October 31, 2018
    Date of Event
    September 25, 2018
    Report Date
    October 31, 2018
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIM
    PMA / PMN Number
    P050019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT STENT PARTIAL DEPLOYMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE CAROTID VESSEL. A 10.0-37 CAROTID WALL STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, AT THE TIME OF IMPLANTATION, THE PROXIMAL PART OF THE RELEASE SYSTEM WAS DAMAGED, LEAVING ONLY 40% OF THE STENT'S SURFACE OPEN. A DIAGNOSTIC CATHETER WAS ADVANCED TO MAKE AN EXCHANGE OF GUIDE AND THE STENT WAS RELEASED. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    865040 CAROTID WALLSTENT STENT, CAROTID NIM BOSTON SCIENTIFIC CORPORATION 26605 0020781504

    Patients

    Seq Age Sex Outcome Treatment
    1