BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAROTID WALLSTENT MONORAIL ENDOPROSTHESIS

    MDR report key: 1981967 · Received February 8, 2011

    Report

    Report Number
    2134265-2011-00423
    Event Type
    Injury
    Date Received
    February 8, 2011
    Date of Event
    September 3, 2010
    Report Date
    February 3, 2011
    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

    (B)(4).

    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).

    Description of Event or Problem · 1

    SAME CASE AS MFR REPORT #: 2134265-2010-05872. (B)(4) STUDY. IT WAS REPORTED THAT DURING A CAROTID ARTERY STENTING TREATMENT PROCEDURE THE PATIENT EXPERIENCED A VESSEL SPASM, NO FLOW, LOW BLOOD PRESSURE, AND THROMBUS FORMATION. THE TARGET LESION WAS LOCATED IN THE LEFT COMMON CAROTID AND INTERNAL CAROTID ARTERY. THROMBUS WAS PRESENT PRIOR TO TREATMENT. THE FILTERWIRE EZ WAS DEPLOYED AND THE PATIENT EXPERIENCED LOW BLOOD PRESSURE RELATED TO A BALLOON DILATION, VESSEL SPASM FOLLOWING FILTERWIRE EZ BASKET EXPANSION, AND NO FLOW DUE TO THE SPASM. THE 10X24MM CAROTID WALLSTENT WAS PLACED AND MICROTHROMBUS WAS NOTED. THE PATIENT WAS TREATED WITH THROMBUS ASPIRATION AND MEDICATION. THE EVENTS WERE RESOLVED NINE DAYS LATER. THE INVESTIGATOR ASSESSED THE THROMBUS EVENT AS RELATED TO THE CAROTID WALLSTENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED INDICATED NO ACTION WAS TAKEN TO TREAT THE VESSEL SPASM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAROTID WALLSTENT MONORAIL ENDOPROSTHESIS STENT, CAROTID NIM BOSTON SCIENTIFIC - GALWAY H7493915010240 0013464036

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention