BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAROTID WALLSTENT MONORAIL

    MDR report key: 1771663 · Received July 27, 2010

    Report

    Report Number
    2134265-2010-03457
    Event Type
    Injury
    Date Received
    July 27, 2010
    Date of Event
    June 15, 2010
    Report Date
    June 29, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIM
    PMA / PMN Number
    P050019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE ROOT CAUSE IS ANTICIPATED PROCEDURAL COMPLICATIONS AS THIS EVENT IS A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE AND IS NOTED WITHIN THE DFU. (B)(4)

    Description of Event or Problem · 1

    (B)(4). SAME CASE AS MFR REPORT #: 2134265-2010-03456. IT WAS REPORTED THAT DURING A CAROTID ARTERY INTERVENTION STENTING TREATMENT PROCEDURE, THE PATIENT EXPERIENCED A BRIEF PERIOD OF UNRESPONSIVENESS. THE INDEX PROCEDURE TREATED THE 80% STENOSED, 4.0X10MM TARGET LESION LOCATED IN THE OSTIUM OF THE RIGHT INTERNAL CAROTID ARTERY. TREATMENT UTILIZED A BSC FILTERWIRE EZ AND PLACED A 10X24MM CAROTID WALLSTENT. FOLLOWING POST DILATION WITH AN UNSPECIFIED BALLOON THE RESIDUAL STENOSIS WAS 0%. DURING THE PROCEDURE, THE PATIENT EXPERIENCED A BRIEF PERIOD OF UNRESPONSIVENESS. NO ACTION WAS TAKEN AND THE EVENT RESOLVED WITHOUT RESIDUAL EFFECTS THE SAME DAY. THE PATIENT WAS DISCHARGED THE NEXT DAY. PER THE PHYSICIAN, THE EVENT WAS LISTED AS "POSSIBLY RELATED" TO THE STUDY DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAROTID WALLSTENT MONORAIL STENT, CAROTID NIM BOSTON SCIENTIFIC - GALWAY M001719040 12971980

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other FILTER WIIREEZ