BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAROTID WALLSTENT MONORAIL

    MDR report key: 1853083 · Received October 5, 2010

    Report

    Report Number
    2134265-2010-04303
    Event Type
    Injury
    Date Received
    October 5, 2010
    Date of Event
    April 2, 2009
    Report Date
    September 9, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIM
    PMA / PMN Number
    P050019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CAROTID STENTING TREATMENT PROCEDURE, PATIENT COMPLICATIONS OCCURRED. THE TARGET LESION BEING TREATED WAS LOCATED IN THE OSTIUM OF THE RIGHT INTERNAL CAROTID ARTERY. THE LESION WAS 85% STENOSED, 6MM IN DIAMETER AND 18MM LONG. DURING THE INDEX, THE PATIENT WAS TREATED WITH A FILTERWIRE EZ AND PLACEMENT OF A CAROTID WALLSTENT. POST DILATION WAS PERFORMED. RESIDUAL STENOSIS WAS 20%. DURING THE INDEX PROCEDURE, THE PATIENT DEVELOPED "RIGHT NECK ACHES AND RIGHT CHEW ACHE." NO ACTION WAS TAKEN AND THE EVENT WAS CONSIDERED RESOLVED WITHOUT RESIDUAL EFFECTS. THE PATIENT WAS DISCHARGED 2 DAYS LATER. THE PHYSICIAN ASSESSED THE RELATIONSHIP TO THE DEVICE AS HIGHLY PROBABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAROTID WALLSTENT MONORAIL STENT, CAROTID NIM BOSTON SCIENTIFIC - GALWAY M001719040 12246811

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other