BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAROTID WALLSTENT MONORAIL

    MDR report key: 1040196 · Received May 8, 2008

    Report

    Report Number
    2134265-2008-01331
    Event Type
    Injury
    Date Received
    May 8, 2008
    Date of Event
    April 7, 2008
    Report Date
    April 10, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIM
    PMA / PMN Number
    P050019
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, A SHAFT BREAK OCCURRED. THE 80% STENOTIC, DE NOVO AND ECCENTRIC LESION WAS LOCATED IN THE CALCIFIED AND SEVERELY TORTUOUS PROXIMAL LEFT INTERNAL CAROTID ARTERY. THE LESION WAS REPORTED TO BE 6.0MM X 20MM AND WAS NOT PRE-DILATED. THE CAROTID WALLSTENT MONORAIL 8.0MM X 29 MM STENT DELIVERY SYSTEM WAS ADVANCED; HOWEVER, SIGNIFICANT RESISTANCE WAS ENCOUNTERED WHEN ATTEMPTING TO CROSS THE LESION. UPON ATTEMPTING TO DEPLOY THE STENT, THE DEPLOYMENT FAILED AND THE PROXIMAL PORTION OF THE SHAFT BROKE. THE DEVICE WAS REMOVED FROM THE PATIENT WITHOUT ADDITIONAL INTERVENTION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A CAROTID WALLSTENT MONORAIL 7.0MM X 40 MM. AT AN UNSPECIFIED TIME, THE PATIENT EXPERIENCED AN ISCHEMIC CEREBRAL ATTACK; HOWEVER, NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. THE PATIENT'S STATUS IS REPORTED AS "STABLE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAROTID WALLSTENT MONORAIL NIM STENT, CAROTID NIM BOSTON SCIENTIFIC 8.0 X 29MM 8873652

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other FILTER WIRE EZ| RIGHT 7F