BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAROTID WALLSTENT MONORAIL ENDOPROTHESIS

    MDR report key: 1874325 · Received October 19, 2010

    Report

    Report Number
    2134265-2010-04607
    Event Type
    Injury
    Date Received
    October 19, 2010
    Date of Event
    August 12, 2010
    Report Date
    September 22, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIM
    PMA / PMN Number
    P050019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: 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).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MFR REPORT #: 2134265-2010-04604, 2134265-2010-04605. CAROTID WALLSTENT / FILTERWIRE EZ (B)(4) POST MARKET SURVEILLANCE STUDY. IT WAS REPORTED THAT FOLLOWING A CAROTID ARTERY STENTING TREATMENT PROCEDURE THE PATIENT EXPERIENCED A CEREBRAL INFARCTION. TWO CAROTID WALLSTENTS WERE ADVANCED OVER A FILTERWIRE EZ AND PLACED IN A 61% STENOSED UNSPECIFIED LESION DURING THE INDEX PROCEDURE. THE SAME DAY POST PROCEDURE THE PATIENT EXPERIENCED AN IPSILATERAL CEREBRAL INFARCTION. THE PATIENT WAS TREATED MEDICALLY WITH NOVASTAN HI AND CATACLOT. THE CEREBRAL INFARCTION WAS CONFIRMED BY A NEUROLOGICAL ASSESSMENT IMMEDIATELY AFTER THE INDEX PROCEDURE. MRI WAS PERFORMED SHOWING THE LOCATION OF CEREBRAL INFARCTION WAS THE IPSILATERAL SIDE (LEFT SIDE). INFARCTIONS WERE SPREAD ACROSS LEFT CEREBRAL AREA. IMMEDIATELY FOLLOWING THE INDEX PROCEDURE THE PATIENT EXPERIENCED RIGHT SIDED PARALYSIS AND INABILITY TO TALK. CURRENTLY, THE PATIENT CONTINUES TO EXPERIENCE RIGHT SIDED PARALYSIS AND A SPEECH DEFICIT LIMITING THE PATIENT TO A SINGLE WORD. THE PHYSICIAN FELT THAT THE EVENT WAS A RESULT OF THE INDEX LESION HAVING VULNERABLE PLAQUE, ATHEROTHROMBOSIS, AND CALCIFICATION. THERE WAS POSSIBILITY THAT DEBRIS WAS RELEASED FROM THE FILTERWIRE WHILE REMOVING THE WIRE FROM THE PATIENT, CAUSING THE CEREBRAL INFARCTION. THERE WAS NO PROBLEM NOTED FOR THE FILTERWIRE. THE PHYSICIAN ASSESSED THE CEREBRAL INFARCTION AS UNRELATED TO THE CAROTID WALLSTENTS. THE PHYSICIAN ASSESSED THE CEREBRAL INFARCTION AS RELATED TO THE FILTERWIRE. TWO DAYS POST PROCEDURE THE PATIENT DEVELOPED HYPERPERFUSION SYNDROME AND CONVULSIVE SEIZURES WHICH WAS TREATED WITH ALEVIATIN. THE PHYSICIAN ASSESSED THE HYPERPERFUSION SYNDROME AS UNRELATED TO THE CAROTID WALLSTENTS AND THE FILTER WIRE.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE PATIENT HAD CONVULSIONS AT THE CLOSURE OF THE INDEX PROCEDURE WITH A NEUROLOGICAL ASSESSMENT PERFORMED IMMEDIATELY AFTER THE PROCEDURE. THEN, MRI WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAROTID WALLSTENT MONORAIL ENDOPROTHESIS STENT, CAROTID NIM BOSTON SCIENTIFIC - GALWAY H749391508210 13354949

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention FILTERWIRE EZ| CAROTID WALLSTENT