BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAROTID WALLSTENT MONORAIL

    MDR report key: 3953370 · Received July 23, 2014

    Report

    Report Number
    2134265-2014-04309
    Event Type
    Injury
    Date Received
    July 23, 2014
    Report Date
    June 30, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIM
    PMA / PMN Number
    P050019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LITERATURE CITATION: MONTORSI, P. ET AL. (2014). CAROTID ARTERY STENTING IN PATIENTS WITH LEFT ICA STENOSIS AND BOVINE AORTIC ARCH: A SINGLE-CENTER EXPERIENCE IN 60 CONSECUTIVE PATIENTS TREATED VIA THE RIGHT RADIAL OR BRACHIAL APPROACH. JOURNAL OF ENDOVASCULAR THERAPY 2014 (21): 127-136. DEVICE EVALUATED BY MFR: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. 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 VIA A JOURNAL ARTICLE THAT THE PATIENT EXPERIENCED A STROKE. A RETROSPECTIVE REVIEW OF PATIENTS TREATED WITH FILTER PROTECTED CAROTID STENTING USING A CAROTID WALLSTENT AS WELL AS NON-BSC STENTS WAS PERFORMED. ONE PATIENT EXPERIENCED A LEFT HEMISPHERE MINOR STROKE THAT RESOLVED COMPLETELY WITHIN 7 DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431339 CAROTID WALLSTENT MONORAIL STENT, CAROTID NIM BOSTON SCIENTIFIC - GALWAY UNK60

    Patients

    Seq Age Sex Outcome Treatment
    1 Other