BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXSTENT MONORAIL

    MDR report key: 1243030 · Received November 21, 2008

    Report

    Report Number
    2134265-2008-04444
    Event Type
    Injury
    Date Received
    November 21, 2008
    Date of Event
    May 28, 2008
    Report Date
    October 23, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIM
    PMA / PMN Number
    P050025
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT 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 MANUFACTURING RECORDS FOUND NO ISSUES OR DISCREPANCIES. THE ROOT CAUSE WILL BE ASSIGNED ANTICIPATED PROCEDURAL COMPLICATION DUE TO KNOWN PHYSIOLOGICAL EFFECT NOTED WITHIN THE DEVICE LABELING.

    Description of Event or Problem · 1

    CLINICAL STUDY. IT WAS REPORTED THAT 231 DAYS AFTER A CAROTID ARTERY STENTING TREATMENT PROCEDURE RESTENOSIS OCCURRED. THE TARGET LESION WAS LOCATED IN THE OSTIUM LEFT INTERNAL CAROTID ARTERY WITH 70% STENOSIS AND WAS 10 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 8. THE PHYSICIAN TREATED THE LESION WITH PLACEMENT OF A FILTERWIRE EZ AND A 4-9 X 30 MM NEXSTENT. FOLLOWING POST-DILATATION THERE WAS 20% RESIDUAL. 231 DAYS AFTER THE INDEX PROCEDURE, THE PATIENT UNDERWENT A CAROTID ANGIOGRAM THAT SHOWED: RIGHT CAROTID; UP TO 20% NARROWING AT OSTIUM OF INTERNAL CAROTID ARTERY AND; LICA: KINKING OF THE STENT FROM PLACEMENT IN THIS AREA AND ECCENTRIC 40-50% STENOSIS. PER THE CATHETERIZATION LAB REPORTED IT WAS NOTED THAT DUE TO THE QUESTIONABLE RESTENOSIS, THE PATIENT WILL BE FOLLOWED CLOSELY. THE SITE REPORTED THAT FOLLOWING THE ANGIOGRAM, THE PATIENT WAS NOT ADMITTED TO THE HOSPITAL. A NEUROLOGY CONSULTATION WAS NOT DONE. THE EVENT WAS NOT RECOVERED/NOT RESOLVED. IN THE OPINION OF THE PHYSICIAN THE RELATIONSHIP TO THE NEXSTENT CAROTID STENT IS POSSIBLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXSTENT MONORAIL NIM STENT, CAROTID NIM BOSTON SCIENTIFIC NA C71401

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Other