BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAROTID WALLSTENT MONORAIL

    MDR report key: 1673268 · Received May 4, 2010

    Report

    Report Number
    2134265-2010-02142
    Event Type
    Death
    Date Received
    May 4, 2010
    Date of Event
    April 4, 2010
    Report Date
    April 8, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIM
    PMA / PMN Number
    P050019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, 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)

    Additional Manufacturer Narrative · 1

    QUESTION 1. A COPY OF ALL CURRENT LABELING FOR THE DEVICE, INCLUDING DIRECTIONS FOR USE, CAUTION STATEMENTS, TECHNICAL MANUALS AND PRODUCT PERFORMANCE REPORTS. QUESTION 2. THE PRIMARY AND SECONDARY CAUSES OF DEATH AS DESCRIBED IN THE AUTOPSY REPORT, IF ANY AUTOPSY WAS PERFORMED. RESPONSE: THE FAMILY INFORMED US THAT AN AUTOPSY WAS NOT PERFORMED. (B) (4)

    Description of Event or Problem · 1

    (B) (4). IT WAS REPORTED THAT AFTER A CAROTID ARTERY STENTING PROCEDURE, THE PATIENT EXPIRED. THE TARGET LESION WAS LOCATED IN THE PROXIMAL RIGHT INTERNAL CAROTID ARTERY WITH A 95% STENOSIS, A LENGTH OF 6 MM, AND A REFERENCE VESSEL DIAMETER OF 5 MM. THE PHYSICIAN TREATED THE LESION WITH PLACEMENT OF A FILTERWIRE EZ DEVICE AND A CAROTID WALLSTENT. FOLLOWING POST-DILATATION, RESIDUAL STENOSIS WAS 30%.THE PATIENT WAS DISCHARGED THE NEXT DAY. AT 9 DAYS LATER, THE PATIENT WAS TAKING A NAP AT HOME, AFTER A COUPLE OF HOURS THE PATIENTS WIFE FOUND HIM TO BE UNRESPONSIVE, APNEIC AND PULSELESS. EMS WAS CALLED. IN ROUTE TO THE HOSPITAL, THE PATIENT RECEIVED THREE ROUNDS OF EPI, ATROPINE AND CPR. THE PATIENT PRESENTED TO THE HOSPITAL WITH AN ARTIFICIAL AIRWAY IN PLACE. BLOOD WAS COMING FROM HIS AIRWAY. HE WAS ASYSTOLIC AT ALL TIMES. HIS PUPILS WERE FIXED AND DILATED. DESPITE APPROPRIATE RESUSCITATION, THE PATIENT EXPIRED. PER THE DEATH CERTIFICATE, THE CAUSE OF DEATH WAS CARDIAC ARREST. IT IS UNKNOWN IF AN AUTOPSY WAS PERFORMED.

    Description of Event or Problem · 1

    (B) (4). IT WAS REPORTED THAT AFTER A CAROTID ARTERY STENTING PROCEDURE, THE PATIENT EXPIRED. THE TARGET LESION WAS LOCATED IN THE PROXIMAL RIGHT INTERNAL CAROTID ARTERY WITH A 95% STENOSIS, A LENGTH OF 6 MM, AND A REFERENCE VESSEL DIAMETER OF 5 MM. THE PHYSICIAN TREATED THE LESION WITH PLACEMENT OF A FILTERWIRE EZ DEVICE AND A CAROTID WALLSTENT. FOLLOWING POST-DILATATION, RESIDUAL STENOSIS WAS 30%.THE PATIENT WAS DISCHARGED THE NEXT DAY. AT 9 DAYS LATER, THE PATIENT WAS TAKING A NAP AT HOME, AFTER A COUPLE OF HOURS THE PATIENTS WIFE FOUND HIM TO BE UNRESPONSIVE, APNEIC AND PULSELESS. EMS WAS CALLED. IN ROUTE TO THE HOSPITAL, THE PATIENT RECEIVED THREE ROUNDS OF EPI, ATROPINE AND CPR. THE PATIENT PRESENTED TO THE HOSPITAL WITH AN ARTIFICIAL AIRWAY IN PLACE. BLOOD WAS COMING FROM HIS AIRWAY. HE WAS ASYSTOLIC AT ALL TIMES. HIS PUPILS WERE FIXED AND DILATED. DESPITE APPROPRIATE RESUSCITATION, THE PATIENT EXPIRED. PER THE DEATH CERTIFICATE, THE CAUSE OF DEATH WAS CARDIAC ARREST. IT IS UNKNOWN IF AN AUTOPSY WAS PERFORMED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Death