BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAROTID WALLSTENT?

    MDR report key: 4260108 · Received November 18, 2014

    Report

    Report Number
    2134265-2014-06987
    Event Type
    Malfunction
    Date Received
    November 18, 2014
    Date of Event
    October 24, 2014
    Report Date
    October 24, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIM
    PMA / PMN Number
    P050019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL/ PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE 85% STENOSED, 50MM X 9MM, ECCENTRIC, DE NOVO TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND NON-CALCIFIED RIGHT INTERNAL CAROTID (RIGHT ICA) ARTERY. AN UNSPECIFIED SIZE NON-BSC GUIDE CATHETER AND NON-BSC GUIDEWIRE WERE ADVANCED TOWARDS THE TARGET VESSEL. SUBSEQUENTLY, A 10.0-37 CAROTID WALLSTENT¿ WAS SELECTED FOR USE AND ADVANCED BUT FAILED TO CROSS THE LESION. THE DEVICE WAS REMOVED AND THE PHYSICIAN NOTED THAT THERE WAS DEFORMATION AT THE END OF THE STENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    746648 CAROTID WALLSTENT? STENT, CAROTID NIM BOSTON SCIENTIFIC - GALWAY H965SCH647140 16683062

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR JR- GUIDE CATHETER| RINATO- GUIDE WIRE