BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAROTID WALLSTENT MONORAIL ENDOPROSTHESIS

    MDR report key: 2001498 · Received February 25, 2011

    Report

    Report Number
    2134265-2011-00328
    Event Type
    Injury
    Date Received
    February 25, 2011
    Date of Event
    August 31, 2010
    Report Date
    January 30, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIM
    PMA / PMN Number
    P050019
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE ELEVATED 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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING A CAROTID ARTERY STENTING PROCEDURE, THE STENT DAMAGE AND RESTENOSIS OCCURRED. THE INITIAL PROCEDURE TREATED A 5-10X15MM, STRAIGHT LESION OF THE COMMON CAROTID ARTERY (CCA) TO INTERNAL CAROTID ARTERY (ICA). A FILTERWIRE EZ WAS PLACED, PREDILATION WAS PERFORMED WITH A 3.5X30MM BALLOON, A 10X24MM CAROTID WALLSTENT WAS PLACED, AND POST DILATION WAS PERFORMED WITH A 4.5X20MM BALLOON. THE PHYSICIAN REPORTED THAT AFTER STENT PLACEMENT, THE LESION BECAME "MORE STRAIGHT" AND THE STENTED SEGMENT FROM THE CCA TO ICA BECAME "NARROW" AND "ELONGATED." NO PROBLEMS WITH THE STENT WERE NOTED ON ANGIOGRAPHY. THE PATIENT WAS SEEN FOR A ONE MONTH FOLLOW UP VISIT AND "CONING" OF THE STENT WAS NOTED WITH SHORTENING ON THE CCA SIDE OF THE STENT. THE PHYSICIAN IMPLANTED A 6X30MM NON-BSC STENT AND POST DILATED WITH A 4X30MM BALLOON. AT THE THREE MONTH FOLLOW UP IN (B)(6) 2010, THE DISTAL PORTION OF THE CAROTID WALLSTENT WAS COMPLETELY RESTENOSED. THE PHYSICIAN FELT THAT POST DILATION OF THE STENT DURING THE INITIAL PROCEDURE MAY HAVE CONTRIBUTED TO THE SHORTENING OF THE STENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAROTID WALLSTENT MONORAIL ENDOPROSTHESIS STENT, CAROTID NIM BOSTON SCIENTIFIC - GALWAY H7493915010240 0013452736

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention